From Fat Chance To Second Chance For A Diet Pill Maker? - Forbes

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Three months after Orexigen Therapeutics shelved further development plans for its Contrave diet pill because the FDA made an "unprecedented" request for additional clinical trial work, the aspiring drug developer has reached an unexpected deal with the agency to proceed with a cardiovascular study.

At issue are concerns over cardiovascular risks that prompted the FDA to request a randomized, double-blind, placebo-controlled trial, which Orexigen execs claimed "would generate significantly more information than is necessary or feasible." Now, though the FDA agreed to a study involving 10,000 patients and would be completed and reviewed by 2014.

"I think this was a multi-pronged effort that we built to create some momentum that helped the process," Orexigen ceo Michael Narachi told analysts on a conference call last night. "…This drug, which we always believed could benefit patients, has a clear path to market" (see a statement here).

The disclosure comes just one week after the FDA agreed to reconsider yet another diet pill. Vivus, which is developing the Qnexa weight-loss drug, will pursue an indication for men and women who do not have the potential to have children, and will resubmit data by the end of October (see this).

The moves suggest that there may – emphasis on 'may' – be a future after all for this latest round of forthcoming diet pills, each of which has suffered setbacks trying to overcome regulatory hurdles. Last year, the FDA also rejected the Lorqess drug from Arena Pharmaceuticals due, in part, to concerns the pill may cause tumors in rats and that efficacy was marginal (back story).

As Leerink Swann analyst Joshua Schimmer wrote in an investor note, "With over 70 million Americans now defined as obese, weight loss has become a major unmet medical need and is a major contributor to significant conditions such as diabetes and cardiovascular disease." This helps explain why the FDA plans to hold an advisory committing meeting early next year to review diet pills.

However, the FDA has been particularly cautious about approving new diet pills. The backdrop, of course, is greater agency emphasis on safety and, in particular, the 1997 withdrawal of Pondimin, which was one-half of the infamous fen-phen weight-loss cocktail and its chemical cousin, Redux, over links to serious heart and lung side effects.

The agency is also concerned that diet pills may be prescribed and used inappropriately. The fen-phen craze spawned a number of so-called pill mills and FDA officials fear that many consumers will rely too heavily on diet drugs without simultaneously altering their diet or exercising more. And with various safety signals showing up in this new trio of pills, the FDA deliberately exercised restraint.

Contrave, by the way, combines two older drugs – the Wellbutrin antidepressant and a sustained release form of naltrexone, an opioid blocker used to treat addictions to alcohol and painkillers, as well as curbing appetites. About four of 10 patients taking Contrave for a year lost at least 5 percent of their weight, an outcome that just met FDA guidelines for effectiveness.

However, Contrave increases blood pressure, a side effect that was also caused by the Meridia that was withdrawn last year after links to heart attacks and strokes (see this). So approval is certainly not a given. After all, one reason for conquering obesity is to lower the risk of such afflictions as high blood pressure. Such issues have prompted speculation that the FDA will require any newly approved diet pill to include a program that has formal patient controls and monitoring.

22 Sep, 2011

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