On Friday (June 17), the FDA is expected to announce its decision on Acura Pharmaceuticals’ (ACUR) Acurox (oxycodone HCl) Tablets for the relief of moderate to severe pain. This is expected to bring a lot of investor interest in the stock in the days leading up to the event. The Acurox Tablets are Acura’s most advanced product and the opioid analgesics market is big. It had sales over $10 billion in 2010, according to BioDelivery Sciences, so if the product candidate gains approval and traction in the market, the opportunity could be huge. King Pharma, which is owned by Pfizer (PFA), is a partner.
The Acurox Tablet has one very important feature that makes it more attractive than some of the products on the market: the tablets are designed to deter common methods of misuse and abuse. According to a Yale study released earlier this month, the number of people using opiods for non-medical reasons rose by 1.2 million – approximately 13% – between 2008 and 2009. That is a big figure for a market that's worth over $10 billion and may make doctors more apt to prescribe it.
For some background, the two companies have been trying to get Acurox approved for a number of years. On Jan. 2, 2009, the first New Drug Application (NDA) was submitted for Acurox Tablets. Shortly thereafter on March 3, the FDA accepted the NDA with a priority review classification. The PDUFA was set for June 30. On June 23, Acura announced that it received a review letter from the FDA. The company said that it did not anticipate approval based on the comments in the letter. On July 2, the company officially announced that it received a Complete Response Letter (CRL) for Acurox. The CRL raised issues regarding the potential abuse deterrent benefits of Acurox. King and Acura met with the FDA on Sept. 2, to discuss the CRL. The FDA and the companies agreed to take the NDA to an FDA Advisory Committee to consider the evidence to support the potential opioid abuse deterrent effects of Acurox Tablets. The FDA also indicated that no new clinical trials would be required at that time.
On April 22, 2010, the two companies announced that the FDA’s Anesthetic and Life Support Drugs and Drug Safety and Risk Management Committees voted that they do not have enough evidence to support the approval of the NDA for Acurox Tablets for the treatment of moderate to severe pain, considering the deterrent effects of niacin as well as the potential deterrent effects of the other features specific to Acurox. On Dec. 20, the two companies announced that King submitted an NDA for Acurox to the FDA, including a request for priority review classification.
On Feb. 14, 2011, Acura announced the NDA for Acurox Tablets was accepted for filing by the FDA with a Priority review classification and a PDUFA date of June 17, 2011. In addition, the FDA’s filing communication letter to King also included preliminary comments about potential review issues relating to an intranasal abuse liability study included in the NDA and requests additional information relating to this study and other issues. The company added that the preliminary notice of potential review issues is not indicative of deficiencies that may be identified during the FDA’s review of the NDA.
Acura’s stock was on a tear until recently, more than doubling from last October’s low of $2.20 to a high of $5.45. After that, the stock has stumbled over 30% to yesterday’s closing price of $3.79. Financially, the company has not been doing well. The company’s revenues are very limited and were just $0.2 million in its last quarter vs. $2.0 million in the year ago quarter; EPS was ($0.06) vs. ($0.09) a year ago. Note, BioDelivery Sciences (BIOD) may trade on ACUR’s news as it also has an opioid analgesic, BEMA Buprenorphine, which it is developing. The product candidate is in Phase 3 trials.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.