Those who argued there was a 'fat chance' the FDA would approve the Arena diet pill were correct. The drugmaker issued a statement this morning saying the agency sent a complete response letter and the rejection can be attributed to waiting for results of a trial in patients with diabetes, concerns the Lorqess pill may cause tumors in rats and that efficacy was marginal.
The outcome is hardly surprising, given the issues raised by FDA reviewers at an advisory committee meeting (look here). The session may have prompted outrage among some investors, who generated considerable attention by circulating a petition insisting FDA staff was biased, but the agency is exercising considerable caution these days over safety issues (back story). This is especially true for diet pills after more than a decade of safety surprises, even though obesity remains a huge problem.
"With respect to the clinical reasons, the FDA stated in the CRL that the weight loss efficacy of lorcaserin in overweight and obese individuals without type 2 diabetes is marginal...," the Arena statement says. "The FDA also stated in the letter that in the event evidence cannot be provided to alleviate concern regarding clinical relevance of the tumor findings in rats, additional clinical studies may be required to obtain a more robust assessment of lorcaserin's benefit-risk profile." Lorcaserin is the chemical name for the drug, by the way.
The upshot: the Arena pill is unlikely to wind up on pharmacy shelves for a year or more. And if it does, the FDA is also recommending that it be placed on Schedule IV of the Controlled Substance Act, which includes drugs that may lead to limited physical dependence or psychological dependence. Investors may have smelled a rat, but they shouldn't have been surprised.
6 Comments
It seems to me as if the FDA deliberately delayed the announcement until this morning so as not to roil the markets. Investor sentiment should never be taken into account in the timing of these announcements. To me this is more egregious than which ever way the decision might have gone.
Of equal concern is the possibility that lorcaserin could wind up as a Schedule IV drug based on the CRL. Here are the stringent DEA requirements for storage of Scheduled Drugs under the Controlled Substances Act. I don't know any phycisians who have these at the moment, and I doubt that many will be making the necessary investments and dealing with the voluminous paperwork for the purpose of diepensing a diet pill.
Abuse liability studies in animals are fairly standard for diet drugs. Something must have turned up in animal data on lorcaserin to concern the FDA in this regard.
http://www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual012508.pdf
If it were to be a scheduled drug, most likely the company would dispense trial vouchers to MD offices. That would likely only go on for a while - just until the company could build consumer demand, and be confident that MDs had enough clinical exposure to actually prescribe it. They would not likely bother with samples.
MD offices actually should keep a log of samples received and dispensed since that would be the only way to track medication safety/recall issues.
It would be only a minor burden that a schedule IV drug can not carry more than 5 refills before a new prescription. Even if there were not data in animal studies suggesting dependence/abuse risk, human nature, and the treatment goal are such that abuse and (at least psychological) dependence are very likely.
I think the reason for limiting refills is to avoid patients taking above the approved dose. The drug is presumably more effective at higher doses, but there is a theoretical risk of cardiac valvulopathy due to its weak affinity for the 5HT-2b receptor. This is the receptor to which Fen-Phen valvulopathy is attributed.
Thanks, Dr. Helm. Personally I would not allow for 5 refills of any Scheduled drug. 4-5 months is easily long enough to get hooked on a Sched IV med. Every doctor practices differently, but in my state we have approximately 52,000 lawyers, and if I wrote a scrip for a Sched IV drug with 5 refills, did not see the patient for 6 months, and there were a serious adverse event or other potentially serious consequences I would be wide open to a malpractice suit. One 30 day Rx with zero refills is how I would proceed with this drug. However, it is all academic since I think that the DEA Diversion Unit will be monitoring this one carefully, and distribution will be tight. Remember, amphetamines were another class of unscheduled diet drugs until their abuse got out out of control, and they became scheduled. That's another reason that I think that DEA will keep a close watch on this one.
It's magnificent how those celebrity done to their bodies. Some celebrity had just become a mother & within really short time they were able to lose all those weight gain. It looks like either they have really good nutritionist or they just perfectly chose diet programs. I have been trying many diet programs & pills and have posted my progress as well as tips & reviews on my blog at www.dietAlt.com.