Pfizer

FDA approves Pfizer pain drug Oxecta

pharmafile | June 21, 2011 | News story | Sales and Marketing FDA, Oxecta, Pfizer, chronic pain 

The FDA has approved Pfizer and Acura’s novel pain drug Oxecta, but will require follow up studies to prove its anti-abuse potential.

Oxecta – formerly known as Acurox – is now licensed for the management of acute and chronic moderate to severe pain, where the use of an opioid analgesic is appropriate.

Oxecta is a short-acting painkiller consisting of the narcotic oxycodone – mixed with other ingredients developed by Acura.

This novel formulation of the drug makes it hard for drug addicts to crush or dissolve the tablet, thereby reducing the potential for abuse.

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But the companies acknowledged the potential for abuse was not completely removed and because of this, analysts are predicting modest sales of $30 million a year for the drug.

Oxecta is expected to be launched by the fourth quarter, but the FDA has told Pfizer it must conduct post-marketing studies to examine whether the drug does in fact lower the risk of abuse and misuse.

In 2009 the FDA rejected the original Acurox formulation. This included the vitamin niacin, an ingredient that can cause redness and irritation of the face when taken in excess.

Pfizer acquired these marketing rights through its $3.6 billion purchase of King Pharmaceuticals in March this year, and will give Illinois, US-based Acura milestone payments and royalties based on sales, including $20 million based on this week’s approval.

Olivier Brandicourt, Pfizer’s president and general manager of primary care, said: “Oxecta will further expand Pfizer’s presence in pain management and complements our growing, robust portfolio of treatments and medicines in development for pain relief, one of our strategic, high-priority disease areas.”

News broken on Twitter

In a unique, though thoroughly modern, twist to the story, news of the FDA’s approval was first broken on the micro-blogging site Twitter by a biotech stock blogger.

After receiving confirmation from the FDA Geoff Chambers posted news of Oxecta’s approval on his Twitter account three days before either the regulator or Pfizer officially announced the decision.

Ben Adams

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