antidepressant

FDA OKs Wyeth's antidepressant Pristiq

Mon, 03 Mar 2008 06:59:56 -0500

Wyeth announced late Friday that it won FDA approval for Pristiq, its next-generation version of the antidepressant Effexor. Wyeth was looking for an approval of Pristiq to offset the considerable losses that are likely to follow Effexor's loss of patent protection in 2010. Pristiq is a norepinephrine reuptake inhibitor, as is Effexor. But researchers say the drug can be used in therapeutic doses from the day it is prescribed, as opposed to the steadily ascending doses that doctors currently prescribe Effexor.

The approval came with strings. Wyeth has to conduct a string of trials covering long-term maintenance, sexual dysfunction, pediatric studies and lower-dose studies.

- here's the release on the approval
- read the report from TheStreet

Related Articles:
Wyeth presents Pristiq data. Report
Wyeth's Pristiq shows benefits in clinical trial. Report
FDA issues approvable letter for Pristiq. Report
Wyeth expects provisional OK for Pristiq. Report

Studies inflating antidepressant efficacy?

Fri, 18 Jan 2008 06:59:54 -0500

Yesterday we reported on an article published in the New England Journal of Medicine that found studies with positive results were far more likely to be published than those with negative results. The study found that the FDA is working with raw data, whereas medical journals are not, which can contribute to misleading results about the efficacy of certain drugs, particularly antidepressants. And the folks over at the blog Clinical Psychology and Psychiatry have an in-dept look at exactly which antidepressants may have inflated benefits due to data suppression. The list includes Wellbutrin, Celexa, Cymbalta, Lexapro, Prozac, Remeron, Serzone, Paxil, Zoloft, and Effexor--every antidepressant approved between 1987 and 2004.

- see this blog entry for more

Related Article:
Positive data more likely to find its way to public. Report
Top 10 drug warnings and recalls of 2007: Antidepressants

Insomnia market attracts drug developers

Mon, 08 Oct 2007 06:59:54 -0400

The market for insomnia drugs in the U.S. is growing at a whopping 29 percent per year, hitting $4.6 billion in 2006 and attracting the attention of a wide range of drug developers. More than a dozen compounds are in mid- to late-stage clinical trials in a race to capture a market that includes some 70 million Americans who suffer from chronic or occasional insomnia. Among the leaders in that race, according to analysts, are Somaxon and Neurocrine Biosciences, both of which are looking for near-term FDA approvals on late-stage drugs. Somaxon researchers believe that their therapy, which relies on an old antidepressant, will work by blocking the release of histamine at the H1 receptor in the brain.

- here's the report from BusinessWeek

Related Articles:
Somaxon touts latest Phase III results for Silenor. Report
FDA wants more data on Neurocrine's indiplon. Report
Arena Pharma produces positive insomnia data. Report

Sanofi underscores pipeline advances, setbacks

Mon, 17 Sep 2007 06:59:55 -0400

Sanofi-Aventis had some good news and some bad news to deliver to analysts during its first pipeline update in two years. On the down side: Its Alzheimer's drug Xaliproden failed late-stage trials. But its antidepressant saredutant passed its late-stage trials, setting up a schedule to file for approval in Europe and the U.S. next year. Another antidepressant, Amibegron, met its primary goal in only one out of four clinical trials.

Sanofi research chief Marc Cluzel (photo) underscored his commitment to the obesity drug Acomplia, though he acknowledged that the drug now faces a long delay in the U.S. Sanofi also announced that it has 48 therapies in late-stage development and expects to file on 31 of them by the end of 2010.

- see Sanofi's release on the pipeline
- read the AP report from Paris

Related Articles:
What's Warren Buffett buying now? Report
Sanofi shares plunge on Acomplia rejection. Report
Sanofi shares slide as FDA delays Acomplia-again. Report
Sanofi signs stem cell pact in China. Report

SPOTLIGHT: Clinical Data upbeat on antidepressant

Thu, 06 Sep 2007 06:59:53 -0400

Shares of Clinical Data got a modest boost on the news that its late-stage study of the antidepressant Vilazodone produced positive results. A companion pharmacogenetic test may make it easier to identify the patients most likely to benefit. Release

ALSO NOTED: Bavarian Nordic, GSK drop vaccine pact; UCB preps for FDA meeting; Lilly and Shionogi in co-development deal; and m

Thu, 01 Feb 2007 19:01:30 -0500

> Bavarian Nordic and GlaxoSmithKline have dropped their agreement to jointly market Imvamune, a smallpox vaccine now in development. When the deal was signed in 2004 Bavarian Nordic didn't have the production capacity needed but says it can commercialize the therapy now on its own. Report

> Responding to rumors of pipeline trouble, UCB says it will meet with the FDA soon to discuss the agency's questions regarding its marketing application for the Crohn's drug Cimzia. Report

> Shionogi and Eli Lilly Japan have agreed to co-develop and co-market the antidepressant duloxetine hydrochloride in Japan. Release

> Molecular Insight Pharmaceuticals has priced its IPO at $14 a share after originally giving a range of $14 to $16. Report

> Adnexus Therapeutics has issued "encouraging" Phase I results for its cancer therapy CT-322. Release

And Finally... A new study indicates that persuading women to volunteer for clinical trials will depend a great deal on a researcher's ability to gain their trust that the trial will be conducted ethically and with their best interests in mind. Release

GSK accused of distorting antidepressant data

Sun, 28 Jan 2007 19:01:37 -0500

The BBC says it will air a program tonight that claims GlaxoSmithKline distorted trial data in an attempt to gain regulators' approval to use the antidepressant Seroxat as a therapy for children. The report claims that Glaxo covered up the drug's link to teen suicide and hid the fact that the drug had failed clinical trials. Glaxo, though, flatly rejected the report's conclusion, saying it never hid any data and brought the information to the attention of regulators.

- check out the press release from the BBC
- read GSK's statement on the accusations
- read the BBC's online report

ALSO: European regulators have agreed to review Glaxo's pre-pandemic flu vaccine. Report

Related Articles:
Study highlights link between Paxil and suicide. Report
GSK prepares to go head-to-head with Merck. Report
Glaxo forges $2.1B deal for HuMax-CD20. Report
GSK sees success with RLS campaign. Report

FDA approves Pristiq for depression

Tue, 23 Jan 2007 19:01:34 -0500

The FDA has issued an approvable letter to Wyeth for its antidepressant Pristiq. "The approvable letter is in line with Wyeth's expectations and we remain on track with our plans for Pristiq," says Joseph Mahady, President, Wyeth Pharmaceuticals, the Americas and Global Businesses. "We are working toward resolution of all outstanding issues at our manufacturing site in Guayama, Puerto Rico and have already made significant progress in meeting previously established commitments."

- here's the release on Pristiq

Related Articles:
Wyeth expects provisional OK for Pristiq. Report
Solvay expands development pact with Wyeth. Report

Wyeth expects provisional OK for Pristiq

Sun, 21 Jan 2007 19:01:34 -0500

Wyeth is signaling that the FDA is likely to extend tentative approval for Pristiq, an antidepressant, but that the agency is likely to ask for more data. The drug is a derivative of Effexor, a blockbuster that will lose patent protection in 2010. Ultimately, though, analysts believe that Pristiq's biggest potential may be for treating menopause. Antidepressants have proven effective in treating the symptoms of hot flashes without posing the risks now linked to hormone replacement therapy.

- read the report on Wyeth from the Philadelphia Inquirer

Related Articles:
Solvay expands development pact with Wyeth. Report
Biotica inks $195M licensing deal with Wyeth. Report

Biovail loses effort to stop generic Wellbutrin

Wed, 13 Sep 2006 20:01:34 -0400

Biovail has lost a last-ditch attempt to prevent copycat versions of its popular antidepressant Wellbutrin from hitting the market. A federal judge has ruled against a move to gain a temporary restraining order and an injunction against the FDA to prevent it from approving a generic. The ruling clears the path for Anchen to start selling a competing generic.

- here's the AP report on the ruling