Investopedia: Pleasure And Pain For Pfizer

Biotech and pharmaceutical investors got another reminder that the FDA can deliver pleasure or pain with the stroke of a pen, and oddly enough Pfizer (NYSE:PFE) was in the middle of all of it. While the FDA granted approval for a tamper/abuse-resistant immediate release formulation of oxycodone developed by Acura Pharmaceuticals (Nasdaq:ACUR) (and Pfizer), the same agency rejected an application for Remoxy - a long-acting abuse-resistant oxycodone formulation that involved Pfizer, Pain Therapeutics (Nasdaq:PTIE) and Durect (Nasdaq:DDRX).

Acura's Long Road to Approval
While Acura's management is no doubt happy to get the FDA's approval on Oxecta, it was not an easy process. The FDA rejected a prior application for a version of the drug that included niacin in June of 2009 and then an FDA advisory panel rejected a resubmitted application in April of 2010. Apparently the third time (this time for the version without the niacin) was the charm, and Acura is now in line to receive a $20 million milestone from Pfizer, and royalties ranging from 5 to 25% of sales.

There is no question that oxycodone abuse is a serious issue. Those inclined to abuse pain medication will take the pills with alcohol or crush them (later to snort or melt and inject) to achieve what's called "dose dumping" - getting all of the effect at once. Odd as it may sound, doctors are increasingly coming under scrutiny for their role in giving prescriptions to drug-seeking patients, and that has made some hesitant to prescribe powerful (but necessary) pain medication like oxycodone. Theoretically, then, there is a big market waiting for a pain drug that cannot be readily manipulated.

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