Elite Pharmaceuticals Inc (ELTP)

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http://www.evaluatepharma.com/Universal/View.aspx?type=Story&id=248098§ionID=&isEPVantage=yes

Oxecta FDA approval tempered by lack of abuse resistance claim

Source EP Vantage
Company Acura Pharmaceuticals, DURECT, Pain Therapeutics, Pfizer
Date June 21, 2011
Acura’s ostensibly abuse-resistant formulation of oxycodone, Oxecta, got approval from FDA but with a disappointment on the label: it includes an explicit statement that the pill does not in fact reduce the danger of abuse. Combined with the agency’s call for partner Pfizer to conduct an epidemiological study of whether the new formulation of the pain reliever deters abuse, Oxecta is looking to be a drug with a limited marketing edge for now.

Acura investors initially took some heart in the approval, and the $20m milestone from Pfizer that came with it, by driving shares up 75% to $6.80 soon after market opening yesterday. However, the stock quickly fell back to $4.50 at close, just a 16% gain, and so far have declined a further 9% in early trade today to $4.08 - no tangible net gain compared to last week's prices. The tempering of investor optimism reflects an understanding that unless Pfizer’s post-approval trial can prove that Oxecta reduces misuse, partnership income will be restricted.