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.)

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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)

Continue reading “Pristiq receives approval from FDA”

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…

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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."

Continue reading “Pristiq's FDA Chances: Depression – Yea; Menopause – Nay”

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.

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.