Pristiq (desvenlafaxine) information

Here’s a list of compiled links providing information on Pristiq. These links include info from my blog and others.

Advertisements

Done deal: Pfizer buys Wyeth for $68 billion

Pfizer-Wyeth merger

The New York Times puts it this way:

The deal, if completed, would not only create a pharmaceutical behemoth but would be a rarity in the current financial tumult: a big acquisition that is not a desperate merger of two banks orchestrated by the government. [emphasis mine]

Funny the writers decided to add that. A year ago, that clause would have never been considered yet alone thought of.

Pfizer isn’t doing badly; in fact, despite the credit crunch, they’ve been able to snag $22.5 billion in loans since they also have $26 billion cash on hand. The NYTimes also reports that this merger would be the biggest since AT&T and BellSouth merged back in March 2006. But of course, with mergers always come layoffs. And what a time to have layoffs. Pfizer today announced that they’ll be cutting 8,000 jobs.

But as I said in a previous post, Pfizer’s biggest challenge is get some pipeline products out to market soon since some of the patents on their big names (ie, Lipitor) are expiring soon. Don’t hold me to this but I think Wyeth has a bit more sitting in their pipeline, hence why the merger would make sense. But I hope Wyeth can produce a new blockbuster drug for Pfizer otherwise Pfizer’s really going to be hurting for money. Especially since Wyeth’s best-selling drug, Effexor, is now generic and Pristiq isn’t completely cutting it.

Pfizer may be buying Wyeth

Pfizer-Wyeth merger

Is Wyeth being hurt by the failing economy? I’m not so sure but Pfizer may be buying up Wyeth for up to $60 million. According to news reports, this could help the pharmaceutical giant by bringing in some of Wyeth’s brand name products while many of Pfizer’s own manufactures (think Lipitor) go generic. However, it could also be a drawback as one of Wyeth’s biggest sellers—our favorite antidepressant Effexor (venlafaxine)—has gone generic. Also, Pfizer doesn’t have the best track record of buying up other companies and turning them into blockbuster gold. Should be interesting to see what happens in the next few years if the deal does go through.

Pristiq's side effects: Too close to Premarin and Prempro for comfort?

Back in January 2007, I’d mentioned that Wyeth was not only seeking to market Pristiq (desvenlafaxine) for depression but also for the use of vasomotor symptoms in menopausal women.

I just learned that Wyeth produces two major menopause drugs, Premarin and Prempro, that allegedly has produced hormones causing cancer in more than 5,000 women. This added up to a loss of 40 million users and $1 billion annually.

With Effexor going generic in 2 years and the introduction of Pristiq to the market, Wyeth hopes to lure some of those customers back and net an annual $2 billion. However, serious questions linger about Pristiq’s side effects in menopausal women.

Why did two women in the study group taking Pristiq have heart attacks
and three need procedures to repair clogged arteries compared with none
taking placebo? How can Wyeth assure long term safety when 604 of the
2,158 test subjects took Pristiq for only six months and 318 for a year
or more? And what about serious liver complications seen in the studies?

Martha Rosenberg, reporting on Pristiq’s use as a menopausal drug, culled comments from CafePharma’s message boards and found one thread rife with mixed comments on the new drug. From an Anonymous commenter:

Read the rest of this entry »

John Grohol interviews Wyeth's VP of Medical Affairs on Pristiq

Dr. Grohol interviewed Dr. Phil Ninan, Wyeth’s VP of Medical Affairs on Pristiq, its efficacy, and surrounding issues. It was quite an interesting interview (and long) but here are some highlights that I chose to comment on. I’ll be making some comments in between Dr. Ninan’s answers due to the extensive length. Some parts of the answers have been truncated.

Read the rest of this entry »

Pharma's "me-too" drugs face skeptical docs and health insurers

As patents expire on a variety of drugmakers’ moneymakers, pharma companies have gone to great lengths to structurally reinvent the successful drugs then tout the benefits that differ from their predecessors.

InvegaCase in point — Johnson & Johnson’s Invega. Invega is the successor to the popular antipsychotic drug, Risperdal, and competitor to AstraZeneca’s widely used antipsychotic Seroquel. Scott Hensley at The Wall Street Journal’s Health Blog (WSJ) reports that Risperdal is going generic in June. Gianna at Beyond Meds recently said it will not. According to the Dow Jones Newswires (DJN), these “junior” drugs face skepticism from health insurers and doctors. California-based Kaiser Permanente and Minneapolis-based UnitedHealth Group Inc. (UNH) are example of companies that have somewhat discouraged use of the drug. Kaiser doesn’t cover Invega at all, and members of UNH are required to pay higher copays for the brand name. The wire reports New York-based psychiatrist Jeffrey Lieberman wasn’t “buying it” the difference between Invega and Risperdal.

Invega is “basically a me-too drug, and the company hasn’t done the studies that would be required to really distinguish it,” Lieberman, chairman of the psychiatry department at Columbia University’s medical school told Peter Loftus of Dow Jones Newswires.

Ouch.

The blog also quotes Daniel Carlat from the The Carlat Psychiatry Report.

Dan Carlat, a psychiatrist and a tough critic of Invega, wrote that J&J’s “marketing team apparently missed the fact that the word in the English language that sounds most like “Invega” is “inveigle,” meaning “to entice, lure, or ensnare by flattery or artful talk or inducements.’ ” He asked doctors: “Will you be doing your patients a favor by taking the plunge? Or will you simply be giving them the same wine in a fancier bottle?”

Even J&J’s Group Chairman of Pharmaceuticals, David Norton, admitted that Invega is a tough sell.

“We need to do a better job at drawing a differentiation in a difficult-to-treat population.

So far, Invega sales have been incredibly disappointing compared to the Risperdal blockbuster.

Wyeth (antidepressant Effexor XR cum Pristiq) and Shire (ADHD drug Adderall XR cum Vyvanse) face the same uphill battle. Wyeth’s Effexor faces generic competition from Teva Pharmaceuticals despite efforts to halt generic sales of the drug and the patent on Shire’s Adderall is set to expire next year.

Hensley, in his analysis, raises a question in which the answer remains to be seen:

Cheap generics abound to treat a broad assortment of illnesses these days. What’s the point, the critics ask, of paying more for drugs that are at best only slight improvements over tried and true medicines available at bargain prices?

It’s something that I’ve questioned myself.

In an attempt to have the “me-too” drugs compete with its derivative, both Wyeth and Shire are slashing their prices, or as the DJN reported, “emphasizing improved dosing for the newer drugs.” Although Pristiq’s efficacy comes at higher doses, it’s being priced 20 percent lower than Effexor.

[Deutsche Bank pharmaceutical analyst Barbara Ryan] thinks the odds of
Pristiq’s success are slim because it appears to offer few benefits
beyond those of Effexor.

That remains to be seen. So far, a few patients have commented on my blog that Pristiq has already begun to help them. I haven’t seen any DTC ads for Pristiq so I can only assume that drug reps are doing a fine marketing job at selling the different benefits of the drug to doctors.

Vyvanse, on the other hand, is looking promising for Shire, already having 7 percent of U.S. ADHD drug prescriptions. Chief Executive Matthew Emmens says the drug is chemically different from Adderall (aren’t they all?) and has better pricing. Shire expects to beat Adderall’s 26 percent peak market share. Seems like a lofty goal to me.

As for Invega, J&J is currently seeking FDA approval to use the drug for bipolar disorder and not just treatment for schizophrenia. It is also l0oking to get approval for an injectable Invega XR.

(Invega logo from Janssen.com)

Poor Wyeth — New drug delayed in FDA approval

From Forbes.com:

Wyeth Pharmaceuticals just can't seem to catch a break. The company is not only increasingly worried that it will lose a large chunk of its revenues to generic competition, it also faces the ongoing threat that its pipeline is starting to go dry. A further delay in the approval of its postmenopausal osteoporosis drug has become one more nail in the pharma company's coffin.

The drug, bazedoxifene, has had a hard time getting approval from the FDA since April 2007.  The FDA is concerned about bazedoxifene's effects on causing myocardial infarctions or blood clots.

This is some pretty disheartening (to say the least) news considering that Effexor will soon be going generic and Pristiq has received some less-than-stellar reviews.

My official position on pharmaceutical companies and psychotropic meds

In previous posts, perhaps I’ve come off a little bit as “I hate Big Pharma.” I did. For a while.

I’m not in love with pharmaceutical companies either. I’ve quoted it before but “to whom much is given, much is required.” As a result of accumulating knowledge through reading and research, I know a whole lot more about pharmaceutical companies, the treatment options they put out there, and what lengths they go to get those treatments out there. Most of the things I read are negative. Much of what I’ve said is negative. Perhaps “ignorance is bliss.” My husband said this recently:

“The Internet is the great bitching ground. No one’s going to talk about how great medication is. Everyone’s going to go on and just bitch about side effects and bad experiences.”

I agree. “Effexor really helped me feel better today” doesn’t make for an interesting blog post. No one pays attention to medication when it’s working, however, everyone will complain if something is going wrong. The most “positive” drug comments I’ve seen are on my seemingly “negative” posts from people who are being helped by a drug.

Take, for instance, the following comment from Suffering:

Read the rest of this entry »

Wyeth Pushing Pristiq Hard

PristiqThe Wall Street Journal reports that Wyeth, desperate to make money off of its Effexor XR-knockoff, Pristiq, says it will slash the antidepressant at a 20% discount compared to Effexor’s price. The price slash, CNN money reports, is a result of less-than-impressive clinical trial data on Pristiq’s “safety and effectiveness.”

Wyeth SVP Joe Mahady told analysts that Pristiq will sell for a flat $3.41 per tablet for both mid- and high-dose, Dow Jones Newswires’ Peter Loftus reports.

Wyeth, apparently, has done this in the past. Back when it was known as American Home Products, the company slashed its price on Protonix, its heartburn drug, to compete with AstraZeneca’s Prilosec. The drug generated $1.9 billion in profits for Wyeth last year. CNN Money reports that Teva Pharmaceuticals and Sun Pharmaceuticals began selling the generic version of the drug and handily cut into Wyeth’s profits: the company reported a 4.6% decline in profit and a 66% drop in sales for the drug for the first-quarter. What will happen with Pristiq remains to be seen. I’m not sure that doctors in 2010 will want to dole out prescriptions for Pristiq when they can save patients—and insurance companies—money by prescribing what will then be known as venlafaxine. WSJ also notes:

A month’s supply of sertraline (Pfizer’s old hit Zoloft) or fluoxetine (Lilly’s Prozac) goes for 50 cents a day at drugstore.com.

$3.41 or $0.50 per tablet. It wouldn’t surprise me if some insurance companies choose to exclude Pristiq from its list of covered drugs. Regardless, Wyeth expects sales of the drug to exceed $1 billion in its first year.

The drug will hit the shelves in May.

Wyeth reps no like Pristiq

Oof. I'm just starting to read The Carlat Psychiatry Blog and stumbled upon this post about Wyeth drug reps trashing Pristiq. Wow. Carlat pulled an excerpt of a Wyeth rep mocking Pristiq's new marketing slogan: "People, Passion, Performance… Pristiq!"

"PEOPLE – 1/2 of you will be gone in less than 27 days

PASSION – There is no passion now, but for those that remain with Wyeth, we will bribe the passion out of you by taking you to Vegas for 4 days.

PERFORMANCE – You thought it was hard to reach your performance incentive before? Wait until 2nd quarter

PRISTIQ – Good luck selling both Effexor XR and Pristiq at the same time. So Dr., would you like to hear about my antidepressant that has been around for 12 years, with proven efficacy with the ability to titrate the dose as need to better care for each patient's needs that will have generic competition in 4 months, or would you like to hear about my brand new antidepressant with one dose, less indications and less evidence of efficacy? You want me to choose, let me check with my bonus plan to see which one pays more."

Carlat:

If this is the typical attitude within the Pristiq sales force, Wyeth may end up a little shy of the blockbuster they were hoping for!

I couldn't have said it better myself.

I hate to brag, but…

I hate to brag, but…

February 28, 2007
Pristiq's FDA Chances: Depression – Yea; Menopause – Nay

It wouldn't surprise me if they said yea to antidepressant use and nay to vasomotor use because of lack of evidence in improved symptoms.

April 19, 2007
Wyeth looking for Pristiq's FDA approval in 2008

I'll follow Pristiq as the information continues to trickle out but don't expect to hear much about it until next year when Wyeth becomes the proud papa of a brand new (and approved) product.

This is one of the few times I can actually say I was right. (Teenage-like "squee!" goes here.)

More recent posts from:

Pristiq receives approval from FDA

PristiqMore than a year ago, I promised to keep tabs on Wyeth’s new (renamed, rather) drug Pristiq. So I’m living up to it.

On February 29, 2008, the FDA granted Wyeth approval to move forward with putting the drug out on the market.

Wyeth said the company planned a big sales effort to introduce the product to psychiatrists and primary care doctors.

There’s a problem with that sentence. I’ll give you a second to figure out what’s wrong with it. Haven’t got it yet?

Primary care doctors. PCP should not be in the business of prescribing or providing psych meds. I’ve gone on and on about it at length before, but I’ll mention it again. PCPs are trained to treat overall conditions that have no need of referral to specialists. Think about it this way: If your psychiatrist prescribed anti-inflammatory medication because you mentioned that you’ve been having problems with your foot, you’d be taken aback, right? If a dermatologist prescribed heartburn medication after a patient mentioned he’d been having heartburn trouble, that would seem almost illogical, wouldn’t it?

(Pristiq logo from Pristiq.com)

Read the rest of this entry »

Wyeth looking for Pristiq's FDA approval in 2008

Depressed Americans will be spared of Pristiq for 1 year. According to an article from Reuters, "positive" data has raised investors’ hopes in Wyeth’s future star drug.

"The trial data showed low doses of Pristiq were effective against both depression and hot flashes and caused less nausea than was seen in prior studies of higher doses. Although the new data will take more time for regulators to analyze, it could bolster prospects for eventual approval and commercial success of the drug."

My best guess? Pharma reps will push Pristiq at higher dosages and doctors will prescribe it at higher dosages with a minimal warning of nausea. I’d like to know the highest dosage tolerated with the least amount of nausea. And really, what is considered a low dosage anyway? The difference between 37.5 mg of Effexor and 300 mg of Effexor is significant despite the fact people told me that the dosages didn’t compare to that of Lexapro’s. (It was supposedly less powerful than Lexapro.)

Anyway, I’ll stop my rants. I’ll follow Pristiq as the information continues to trickle out but don’t expect to hear much about it until next year when Wyeth becomes the proud papa of a brand new (and approved) product.

Pristiq's under-the-radar clinical trials

News stories on Wyeth’s Pristiq, Effexor’s “knockoff”, have focused on the drug’s uses that are pending FDA-approval: vasomotor symptoms accompanying menopause (see hot flashes) and depression. (“Knockoff” term courtesy of CLPsych.) The major media has failed to pick up on Wyeth’s Phase III clinical trials to use Pristiq for fibromyalgia and neuropathic pain (injured tissue or damaged nerve fibers) in diabetics. A search for Pristiq on Wyeth’s Web site yields no results. Desvenlafaxine yields two very meager results.

In related matters, bifeprunox is pending FDA-approval for the use of schizophrenia and is still in Phase III for use of bipolar disorder. They are also in Phase III of testing Lybrex (levonorgestrel) for use for Premenstrual Dysmorphic Disorder in addition to the drug functioning as an oral contraceptive. (I’ll be honest; I had NO clue that diagnosis existed.) In any event, I’ve been misdiagnosed because according to the symptoms, I qualify. I think I also qualify for OOPS – Overdiagnosed and Overmedicated Patient Syndrome.

I’d like expound on Wyeth’s Learn and Confirm phase that’s supposed to replace Phase I and II of clinical trials. It sounds like a speedier way to just get drugs to Phase III of clin. trials, but it’s late and I’m working on something else, so I’ll save that for another day.

Also something to tackle in the future: All these interesting clinical trial results for Effexor XR involving depression and GAD. We’ll see…

digg it | reddit | del.icio.us

Mood: 6.5

Pristiq's FDA Chances: Depression – Yea; Menopause – Nay

As more info on Pristiq continues to roll out, I'll do my best to track them quite closely.

While Wyeth scrambles to resolve issues in its Puerto Rico plant to meet FDA standards, Ms. Kathleen Kerr of Newsday recently reported on Pristiq's potential to be approved for use in depression and hot flashes resulting from menopause. I was so excited to see some decent reporting on a mental health issue in a paper other than the NYT. It was also nice to see that it didn't end with "Shares of Wyeth fell 38 cents Friday to close at $51.50 on the New York Stock Exchange."

"If Pristiq wins Food and Drug Administration approval, it will be the first antidepressant and only non-hormonal remedy marketed specifically for hot flashes. But Pristiq isn't without problems – it poses rare suicide risks in young people."

Read the rest of this entry »

Pristiq gains ground with FDA

FDA approval for Pristiq (I'll refer to it as Pq occasionally) is contingent upon Wyeth's handling of "quality control problems… made to the satisfaction of federal inspectors." As I'd previously mentioned before, Wyeth has built an amazingly similar medication based on Effexor. Wyeth is trying to market Pristiq as an antidepressant and treatment for vasomotor symptoms (hot flashes during menopause). Wyeth is significantly banking on Pristiq since their $3.5 billion Effexor XR will lose its patent in a few years, allowing other companies to make venlafaxine generics.

Some of the "quality control" problems Wyeth is experiencing:

  • unclear whether Pq keeps depressive episodes at bay
  • efficacy at low doses and in young kids
  • severe nausea in 50 percent of patients in the clinical trials

Reuters' article notes this, though:

"But the studies do not need to be completed prior to approval of the new depression pill."

While Wyeth has admitted that Pq is "structurally related" to Effexor, it "has not yet disclosed if Pristiq has any advantages over Effexor XR, other than to say it would be an alternative to existing treatments."

But it has acknowledged the newer drug caused nausea in about one-half of patients in clinical trials.

Wyeth is banking on patients sticking out the nausea for one week (it supposedly subsides after that) or a 50 mg pill that would be more effective than the whopping 400 mg they used in earlier phases of the clinical trials.

"The company said it will not launch Pristiq until it obtains results from the low-dose trials. Moreover, Wyeth said the timing of the launch also will depend on progress of the FDA's ongoing review of Pristiq as a possible non-hormonal treatment for hot flashes. The FDA is scheduled to decide on the hot flashes indication in April."

Wyeth wants to be absolutely sure they can cover all of their bases in an effort not to lose a single portion on their market share — from those who can tolerate low doses at 50 mg to those who need to go 400 mg and up.

"A G Edwards analyst Joseph Tooley has predicted Pristiq will garner annual sales of $1.4 billion by 2011 — about $1 billion from use against depression and the remainder for menopausal symptoms."

Getting not only psychiatrists to prescribe the drug, but also OB/GYNs is a clever move on their part.

Keep an eye out for schizo/psychosis drug bifeprunox

Someone get this on Furious Seasons’ radar:

Wyeth is also in development for an atypical antipsychotic, bifeprunox, for schizophrenia. Bifeprunox has no trade name yet.

“Bifeprunox, a dopamine partial agonist, is an investigational atypical antipsychotic for the treatment of schizophrenia. Clinical data were presented from safety and efficacy studies that evaluated bifeprunox for the treatment of schizophrenia in both acutely psychotic patients and patients who have stabilized disease.

While bifeprunox has been shown to have a smaller mean effect in acute psychosis when compared with older atypical antipsychotics that have some well-known side effects, it may be particularly well-suited for patients who are experiencing side effects with their current therapy. The safety data for bifeprunox have consistently shown a favorable weight and metabolic profile in both short- and long-term studies, which is a common and serious side effect that can cause patients to stop taking their medication.”

A few questions on Wyeth’s schizo drug:

  • How long before this is marketed to bipolar I’s with psychosis?
  • Older atypical antipsychotics or older typical antipsychotics?
  • I’d like to see the data on weight and metabolic profiles on this. Most APs don’t have a good track record with weight, i.e. Seroquel, Abilify, Zyprexa.

Bifeprunox will developing over the coming months and years. I’ll probably check out clinicaltrials.gov in the future to check on updates.

Pristiq posing as pristine

The Trouble With Spikol has linked to an article in the San Diego Union-Tribune (via Reuters) that covers Wyeth's new Effexor XR knock-off, Pristiq (desvenlafaxine succinate). Why are they launching Pristiq? Their patent on Effexor will expire in July 2010 when making generic versions of the drug will be up for grabs.

"Wyeth said in July, however, that it will not introduce Pristiq until it completes tests of a low 50-milligram dose of the drug, following trials of higher dosages in which about half the patients experienced nausea."

Too bad clinical trials don't test for withdrawal symptoms. Will Pristiq avoid the withdrawal hell issues that Effexor XR has?

“'We will wait for the results of the low-dose trials, which we've said we expect in early 2007, before making a decision' on when to launch Pristiq, company spokeswoman Gwen Fisher told Reuters on Friday.

She said nausea seen in the earlier trials was mild to moderate and generally went away within a week after treatment began.”

How long were these clinical trials and if the nausea was seen in the "earlier trials," what about the most recent trials?

Pending FDA approval, Wyeth would also like to use Pristiq for vasomotor symptoms in menopausal women.  Wyeth's unannounced strategy will be to introduce Pristiq long before Effexor's patent expires so they don't lose any of their $1 billion market share to an Effexor generic.

A Wyeth PR that went under my radar:

“Pristiq, a serotonin/norepinephrine reuptake inhibitor (SNRI) now is being studied with a specific focus on women. It initially was developed for two indications that currently are pending approval from the U.S. Food and Drug Administration (FDA) – the treatment of major depressive disorder (MDD) and vasomotor symptoms (VMS) associated with menopause. 

In the area of depression, Pristiq is expected to improve the balance of serotonin and norepinephrine as compared with serotonin reuptake inhibitors (SSRI) because of its pharmacologic profile as a dual reuptake inhibitor.”

Isn’t that what SNRIs are supposed to do?

“Clinical studies confirm that Pristiq is effective in both men and women. However, women over age 40 represent about 50 percent of the depression market and could benefit from an antidepressant that addresses their symptoms and physiology.”

No kidding – 50 percent of the depression market and the implication of all women over 40 years old? Sure, I believe that. Looks like Wall Street doesn't have much hope for the new drug either.

“Pristiq also may be a treatment option for patients who are on multiple medications. The compound has a low risk of drug-drug interactions. This is important when considering that depression often is a co-morbid condition in medically ill patients and that these patients frequently are taking multiple medications. The Company expects FDA action for the MDD indication in January 2007.”

The multiple medications thing. Um, I’m not a fan of that unless it’s absolutely necessary. It isn’t necessary in a lot of cases.

“FDA action for the second application for Pristiq for vasomotor symptoms associated with menopause is anticipated in April 2007. Pristiq is expected to provide significant relief of hot flushes (decrease in number and severity) associated with menopause.

If approved, Pristiq will be the first non-hormonal treatment indicated for relief of VMS.

The Company also plans to pursue indications for Pristiq that would include fibromyalgia syndrome and diabetic neuropathic pain.”

Wyeth certainly is attempting to milk this new drug for all it’s worth. I hope Furious Seasons or CLPsych take up on investigating this one since I simply don’t have the time, resources, or ability.

Well-intentioned but not completely right

medicating the brainI read this commentary from the Philly Inquirer on mental illness and the author insists that mental illnesses are all “chemical imbalances.” While I do think many mental illnesses are the result of chemical imbalances, some mental illnesses are not physical. Some mental illnesses come from a spiritual and/or psychological battle. There are many people who recover from mental illness without medication. If a chemical imbalance was the case for these people, they would never get better. Pharma companies have sold the American public and countless mental health organizations on the idea that millions of people suffer from a “chemical imbalance.” I don’t buy that – well, come to think of it, actually, I do – my dollars contribute to Wyeth and GlaxoSmithKline‘s profits.

After suffering from bipolar disorder (or depression, depending on which psychiatrist I listen to) for 10 years, my husband and I are leaning toward the “chemical imbalance” theory that many doctors and pharmaceutical companies push. But a person who is depressed over a temporary situation does NOT have a chemical imbalance and simply may need psychological counseling.

America is overmedicated, drugged-up, and the victims of the smartest ad campaigns from pharma companies. What concerns me even more is that the FDA and mental health organizations like NIMH buy into many of the pharmaceutical companies’ lies and tactics. What further concerns me are the doctors involved in clinical trials who fail to disclose their affiliations with many of these pharmaceutical companies.

So yes, chemical imbalances do exist for many people. Millions? It’s possible. But unlikely. And I could go off on another rant about how PCPs shouldn’t be prescribing psych meds, but I’ll leave that argument for another day.