A Diet Pill Only For Women Who Can’t Conceive?
2 CommentsBy Ed Silverman // May 3rd, 2011 // 8:07 am
Anxious to win FDA approval for its Qnexa diet pill, Vivus has come up with an unsual fallback position to overcome safety issues that have so far scuttered agency endorsement. If the results of a planned teratogenicity study are inadequate to win over regulators, the beleaguered little drugmaker plans to seek a limited indication. Very limited. This would involve allowing docs to prescribe the diet pill to “only men and women of non-child bearing potential” (read here).
This might seem counterintuitive. After all, diet pills are widely sought by countless women who are still capable of conceiving. For instance, Leerink Swann analyst Steve Yoo estimates in an investor note this morning that about 50 percent of the “likely market could fall into the women of childbearing age.” And more women than men are believed to be willing to pop a diet pill. Yoo notes that in Qnexa Phase III trials, 70 percent to 83 percent were women, “which is typical for obesity therapy.”
In other words, Vivus appears willing to settle for the ’something is better than nothing’ theory of salvaging a project to generate revenue. Of course, Vivus may not get to this desperate stage if the teratogenicity study offers useful results. This retrospective observational study, you may recall, is being undertaken to examine the incidence of oral clefts in babies whose moms took topiramate, which is one component of its Qnexa drug; the other is phentermine, the surviving half of fen-phen (see here).
On the other hand, if the teratogenicity study is a flop, Vivus may have a hard time winning approval, or at least monitoring usage. Once a diet pill is approved, demand is certain to rise. And with demand, comes all manner of efforts to obtain a drug, regardless of restrictions. Even if a risk management plan of some sort is required, many docs are unlikely to want to be put in the uncomfortable position of ensuring patients are incapable of conceiving. Hence, the sales potential would be, well, slim.
Hat tip to Adam at The Street
pic thx to alan cleaver on flickr
industry insider
If this comes to pass, it will be somewhat similar to the Accutane approval and for certain IND drugs, including:
1) women signing an informed consent and an affadavit. stating that they are of non-childbearing potential, attested by their personal physician.
2) barrier contraceptive must still be used in case the drug is taken by the male partner and transmtted in semen.
3) negative pregnancy test before the first RX and at precribed intervals until at least six half-lives after discontinuation.
4) establishment of an international registry for of women who may have become pregnant while taking the drug.
5) establishment of a muiltimillion dollar set-aside fund for the lifetime treatment of fetusess born with teratogenic effects due to the drug.
If the company is ok with that, then go for it. Somehow, I think that such stipulations would make this an unmarketable drug if the company doesn’t pull the plug on it first.
Pelfrey
I say go for it. The criteria are no more cumbersome than many, although I suppose the dollars would have to be closely compared. You have to consider those growing multitudes of overweight baby boomers no longer in their childbearing years (hooray).