On Monday, Orexigen Therapeutics, Inc.(NASDAQ:OREX), the pharmaceutical company said that it would try to negotiate with the Food and Drug Administration to forward the review of an obesity drug which the company has come up with. The company said that they will discuss the issue with the FDA, to get the ball rolling for the regulatory review of the drug, which is called Contrave.
The company is impatient to get their product into the market, and all is not hopeless, since according to them, the Food and Drug Administration might be in a position to negotiate the terms right now. The company wants to negotiate the terms of the review, and forward applications for the review to the FDA to get it out in stores very soon. The FDA, however, is not being stringent and is open to negotiations with Orexigen Therapeutics about their drug. The company wants their drug to go out in the market and start selling soon, and the FDA had already approved two obesity drugs by other companies, so the chances are not quite as slim for Orexigen. Contrave has chances of getting approved by the FDA. The company had been hoping for a marketing approval for their drug within late 2013, and since the FDA approval has to accompany the marketing approval, it would have taken about ten months after that.
However, the company is trying to broaden their study so that they can get to the approval faster. They will be enrolling 9,000 patients, instead of the initial number of 7,000, by the end of this year, so as to get more concrete results. The increase in number will allow for an interim analysis, which in turn, will speed up the approval by the FDA.
The pill for obesity, Contrave, is a combination of anti-depressant ingredient, bupropion, which is present in the medicine called Wellbutrin, and naltrexone, which is a drug used for the prevention of addiction. Contrave had not been able to pass FDA approval in the month of February of 2011.
Shares of the company ended lower by 5% to $5.84 after gaining 4.50% earlier in the session.