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Acura Surges After Winning FDA Approval for Painkiller Oxecta With Pfizer

Acura Pharmaceuticals Inc. (ACUR), a maker of technology to deter drug abuse, rose the most in 11 weeks in Nasdaq trading after U.S. regulators approved its short-acting painkiller Oxecta.

The Palatine, Illinois-based company climbed 63 cents, or 16 percent, to $4.50 at 4 p.m. New York time in Nasdaq Stock Market composite trading. It was the stock’s biggest percentage increase since April 4.

Acura said in a regulatory filing today that it will receive $20 million from Pfizer Inc. (PFE) as a result of the Food and Drug Administration approval. Pfizer, the world’s biggest drugmaker, acquired marketing rights to the pain medicine, formerly known as Acurox, in its $3.3 billion purchase of King Pharmaceuticals in March. Sales of the pills may be limited to $30 million a year because they don’t guard against intentional overdose, according to Ian Sanderson, an analyst at Cowen & Co.

“While the Acura technology does prevent them from being crushed and snorted and chewed, the primary means of abuse is still wide open,” Sanderson said in a telephone interview from Boston. “It really does not have a lot of commercial potential.”

The FDA in 2009 rejected the original Acurox formulation that included niacin, a vitamin that causes redness and irritation of the face when taken in excess.

Photographer: Michele Tantussi/Bloomberg

Pfizer Inc., the world’s biggest drugmaker, and Acura Pharmaceuticals Inc. won U.S. approval for the first short-acting painkiller that discourages users from snorting or injecting it for a quick high. Close

Pfizer Inc., the world’s biggest drugmaker, and Acura Pharmaceuticals Inc. won U.S.... Read More

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Photographer: Michele Tantussi/Bloomberg

Pfizer Inc., the world’s biggest drugmaker, and Acura Pharmaceuticals Inc. won U.S. approval for the first short-acting painkiller that discourages users from snorting or injecting it for a quick high.

Study Requirement

Acura said it expects Pfizer will begin selling Oxecta late in the third quarter or early in the fourth quarter of this year. The FDA is requiring New York-based Pfizer to conduct a study to examine whether the medicine decreases the consequences of abuse and misuse.

“We recognize our responsibility to physicians and patients and remain committed to appropriate access to pain treatment and developing medicines to potentially address this important public health and safety issue,” said Olivier Brandicourt, president and general manager of Pfizer’s primary care division, in a separate statement.

Oxecta is Acura’s first product. The company is entitled to royalties on sales ranging from 5 percent to 25 percent, according to the 2007 agreement with King Pharmaceuticals. Most competing medicines are generic and sold at lower prices than brand-name drugs.

Most abuse of opioid painkillers occurs with extended- release versions. Pfizer is also developing Remoxy, a tamper- resistant form of long-acting oxycodone that is working with Pain Therapeutics Inc. (PTIE) of Austin, Texas, and Cupertino, California-based Durect Corp. (DRRX) The FDA is scheduled to rule on that new drug application by June 23.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.

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