Pfizer, Acura Painkiller Approved by FDA

NEW YORK (TheStreet) -- Pfizer (PFE) and Acura Pharmaceuticals (ACUR) confirmed Monday the U.S. approval of a new tamper-resistant painkiller.

Acura shares were up $2.52, or 65%, to $6.39 in Monday pre-market trading.

The U.S. Food and Drug Administration approved the new opioid painkiller Oxecta on Friday night, but you wouldn't have known it unless you were logged on to Twitter.

Oxecta is a short-acting painkiller consisting of the narcotic oxycodone mixed with ingredients developed by Acura that make it hard for drug addicts to crush or dissolve the tablet to get a quick high. Pfizer will sell Oxecta -- formerly known as Acurox -- in the U.S. and give Acura milestone payments and royalties based on sales.

Oxecta discourages common methods used by addicts to tamper and abuse narcotic painkillers but the drug does not stop abuse altogether, Pfizer and Acura said in announcing the drug's approval.

The FDA does not allow claims of abuse deterrence without data from long-term epidemiological studies that can demonstrate reductions in drug abuse. What the FDA will allow, however, is data and language describing the tamper-resistant qualities of the drug and results from studies that simulate abuse.

The U.S. Food and Drug Administration approved Oxecta late Friday, confirmed spokeswoman Karen Riley, but the agency chose not to make a public statement. Pfizer and Acura didn't say anything publicly about Oxecta's approval on Friday either, choosing to wait for Monday to issue a press release.

With none of the involved parties willing to speak about Oxecta, the public announcement of the drug's approval was made by Geoff Chambers, an economist and biotech stock blogger who tweets under the handle @Gekkowire.

Chambers tweeted "$ACUR approved" at 8:46 pm EDT after getting an email confirmation from FDA spokeswoman Riley.

Oxecta is the first immediate-release opioid approved for the relief of moderate-to-severe pain that is also designed to deter common methods of misuse and abuse. The "typical" patient for such a drug would be someone who just had root canal or some other type of surgery and needs a painkiller for a short period of time -- a few days or up to one month.

Relatively cheap generic drugs currently dominate the market for short-acting opioid pain relievers, so Pfizer and Acura will need the drug's label to adequately describe Oxecta's tamper resistance in order to justify premium pricing.

Extended release, or long-acting, opioids that also aim to deter abuse are already on the market for patients who suffer from chronic pain. Purdue Pharma sells a tamper-resistant form of its popular Oxycontin. Pfizer and Pain Therapeutics ( PTIE) expect an FDA approval decision on June 23 for Remoxy, another long-acting abuse-resistant opioid.

Acura has been trying to get Oxecta, then known as Acurox, approved since January 2009. The FDA first rejected the drug in June 2009. In April 2010, an FDA advisory panel voted against recommending the drug's approval. Acura and King Pharmaceuticals reformulated Oxecta/Acurox and resubmitted it for approval in December 2010. Later, Pfizer acquired King and took over marketing responsibilities for the Acura partnership.

Pfizer will pay royalties ranging from 5% to 25% to Acura, based on levels of sales of Oxecta and other drugs included in the partnership.

-- Written by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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