Stinging FDA review for Acurox – the implications

The US FDA’s advisory panel’s decision to recommend against approval of Acura Pharmaceuticals/King Pharmaceuticals’ Acurox (oxycodone plus niacin) was based upon the view that data were lacking that niacin-induced flushing could potentially reduce misuse of Acurox with single-ingredient oxycodone. The panel also contended that clinical studies were not conducted in populations that might be likely to benefit from the drug’s purported abuse-deterrent properties, such as those with chronic pain and adolescents who are experimenting with drug use.

Previously projected to achieve US sales of $259m by 2018, Datamonitor no longer expects launch to take place

Although the FDA is not bound by the recommendations of its advisory committees, it generally follows their advice. In light of the US FDA’s advisory panel’s decision to recommend against approval of Acurox, Datamonitor believes that subsequent approval of the drug is now unlikely. Based on acceptance of Acurox for priority review by the FDA, Datamonitor had previously expected that US launch of the drug could take place as early as late Q4 2009. Had the FDA approved Acurox, the majority of Acruox sales revenue would have been generated from patients switched from oxycodone instant-release. Datamonitor previously expected Acruox to achieve US-specific sales of around $259m by the end of 2018.

Advisory panel’s decision casts doubt over the future of Acurox’s pipeline candidates which also contain niacin                                                                                                                      

With Acurox representing Acura Pharmaceuticals lead pipeline candidate, subsequent non-approval would represent a substantial blow to the company. Moreover, given that the Advisory Panel of the FDA called into question that niacin-induced flushing could potentially reduce misuse of Acurox, this casts a shadow over the future development of Acura/King’s Acuracet (oxycodone/niacin/APAP) and Vycavert (hydrocodone/niacin/APAP); two early stage pipeline opioids which are designed to deter common methods of misuse and abuse and both contain niacin.

Decision of advisory panel follows 2009 complete response letter for King’s Remoxy                                                                                                                       

For King Pharmaceuticals, the decision of the FDA’s Advisory Panel relating to represent an additional setback following the FDA’s December 2008 issuing of a complete response letter for King’s New Drug Application (NDA) for Remoxy, an abuse-resistant controlled-release form of oxycodone. In July 2009, King announced that resubmission of the NDA for Remoxy to the FDA could occur mid-year 2010. Datamonitor expects Remoxy to generate sales of around $500m in the US by 2018.

However, launch of anti-abuse opioids is not an unattainable goal, as demonstrated by two previous FDA approvals

In August 2009, the FDA approved Embeda (morphine and naltrexone, King Pharmaceuticals). Embeda is designed to work such that, if the capsules are crushed or chewed, the naltrexone would be released, mitigating the euphoric effect of the morphine. Later, in April 2010, the FDA approved a new formulation of OxyContin (oxycodone, Purdue Pharmaceuticals) that was designed to discourage misuse and abuse potential.

Opioids market is set to grow

Despite consisting of numerous reformulations of old drugs, the opioids market in the US grew by 9.3% between 2008 and 2009, to reach sales of $7.6 billion in 2009 (IMS Health. Datamonitor forecasts the  total opioids market across the seven major pharmaceutical markets (US, Japan, France, Germany, Italy, Spain and the UK) to grow as the result of the launch of anti-abuse technologies.

Development of anti-abuse opioids represents a key opportunity for Pharma companies

There is growing concern surrounding the risk of divergence associated with opioid drugs. In particular, abuse and misuse has become an increasingly recognized problem associated with opioids in the US and Purdue Pharma’s Oxycontin (oxycodone) is frequently identified as a drug that is being sold on the black market and abused. In light of this growing concern, Datamonitor believes that the development of anti-abuse opioids represents a key opportunity for companies in this market. The US FDA regards the development of anti-abuse opioids as an issue of high importance, as reflected in the agency’s decision to grant priority review designation to two such products in 2008; Pain Therapeutics and King Pharmaceuticals Remoxy (oxycodone) and Alpharma’s Embeda (naltrexone).