Pfizer's Pain-Free FDA Approval. More to Come?

Pfizer (NYSE: PFE) and Acura Pharmaceuticals' (Nasdaq: ACUR) Oxecta might be abuse-resistant, but it's not approval-resistant. The Food and Drug Administration has approved the pain drug nearly two years after a complete response letter from the FDA.

The drug changed names during the process -- it used to be called Acurox -- but it wasn't brainstorming in the marketing department that caused the long delay. Acura and King Pharmaceuticals, which Pfizer purchased, originally developed the drug with niacin, the active ingredient in Abbott Labs' (NYSE: ABT) cholesterol drug Niaspan. The niacin was supposed to deter drug abuse by making it unpleasant to take more than the recommended dose. Unfortunately, the FDA and an advisory committee weren't hip to the idea, so Acura and King dropped the niacin from the formulation.

Oxecta still contains Acura's abuse-deterrent technology that prevents common methods of tampering -- think snorting and injecting -- but without long-term epidemiological data, the FDA won't let Pfizer and Acura claim that the drug reduces drug abuse. In fact, the product description explicitly states, "There is no evidence that Oxecta has a reduced abuse liability compared to immediate-release oxycodone."

Immediate-release oxycodone, the active ingredient in Oxecta, is available as cheap generics, so Pfizer will have to convince doctors that the threat of abuse is worth the added cost to the patient. Acura certainly hopes its new partner is up to the task. The company is counting on royalties ranging from 5% to 25%, depending on how much Oxecta the company sells.

Through the King purchase, Pfizer has invested substantially in abuse-deterrent pain meds. On Thursday, it's scheduled to hear back about Remoxy, an extended-release, abuse-resistant oxycodone. Pfizer has a different set of partners for Remoxy -- Pain Therapeutics (Nasdaq: PTIE) and DURECT (Nasdaq: DRRX) -- that are eager to see the pharma giant go two for two this week.

Your portfolio giving you pains? Watch this before the market crashes.