PALATINE, Ill.—Acura Pharmaceuticals Inc.announced early April 22 that NASDAQ had halted trading of Acura's common stockfor "news pending," as the Anesthetic and Life Support Drugs and theDrug Safety and Risk Management Advisory Committees to the U.S. Food and DrugAdministration were meeting that day to discuss the New Drug Application forAcurox (oxycodone HCl and niacin) tablets.
The pending news became bad news with a laterupdate by Acura—and by Bristol, Tenn.-based King Pharmaceuticals Inc., which isalso involved with the development of Acurox—that the two committees had votedthat they do not have enough evidence to support the approval of the new drugapplication (NDA) for the drug. The design of Acurox was to have two activeingredients, with the oxycodone to provide analgesia and niacin to minimize thepotential for oral abuse of the drug.
The addition of niacin as a deterrent to abuse wasa central part of the committees' deliberations, and while the FDA isn't boundby the two advisory committees' recommendation, it is likely to take the adviceinto account when reviewing the NDA, and so the outlook isn't good for the drugright now.
Addendum - added April 23, 2010
Acura and King both report that they will workwith the FDA to determine the next steps necessary to continue the Acuroxdevelopment program.
Addendum - added April 23, 2010
From: Datamonitor
Stinging FDA review for Acurox – The Implications The U.S. FDA'sadvisory panel's decision to recommend against approval of AcuraPharmaceuticals/King Pharmaceuticals' Acurox (oxycodone plus niacin) was basedupon the view that data were lacking that niacin-induced flushing couldpotentially reduce misuse of Acurox with single-ingredient oxycodone. The panelalso contended that clinical studies were not conducted in populations thatmight be likely to benefit from the drug's purported abuse-deterrentproperties, such as those with chronic pain and adolescents who areexperimenting with drug use.
FDA Advisory Panel recommends against approval ofAcurox
Previously projected to achieve U.S. sales of $259 millionby 2018, Datamonitor no longer expects launch to take place
Although the FDA is not bound by the recommendationsof its advisory committees, it generally follows their advice. In light of theFDA'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 hadpreviously expected that U.S. launch of the drug could take place as early aslate Q4 2009. Had the FDA approved Acurox, the majority of Acruox sales revenuewould have been generated from patients switched from oxycodoneinstant-release. Datamonitor previously expected Acruox to achieve U.S.-specificsales of around $259 million by the end of 2018.
Advisory panels' decision casts doubt over thefuture of Acurox's pipeline candidates which also contain niacin
With Acurox representing Acura Pharmaceuticalslead pipeline candidate, subsequent non-approval would represent a substantialblow to the company. Moreover, given that the Advisory Panel of the FDA calledinto question that niacin-induced flushing could potentially reduce misuse ofAcurox, this casts a shadow over the future development of Acura/King'sAcuracet (oxycodone/niacin/APAP) and Vycavert (hydrocodone/niacin/APAP); twoearly stage pipeline opioids which are designed to deter common methods ofmisuse and abuse and both contain niacin.
Decision of advisory panel follows 2009 completeresponse letter for King's Remoxy
For King Pharmaceuticals, the decision of theFDA's Advisory Panel relating to represents an additional setback following theFDA's December 2008 issuing of a complete response letter for King's New DrugApplication (NDA) for Remoxy, an abuse-resistant controlled-release form ofoxycodone. In July 2009, King announced that resubmission of the NDA for Remoxyto the FDA could occur mid-year 2010. Datamonitor expects Remoxy to generatesales of around $500 million in the US by 2018.
However, launch of anti-abuse opioids is not anunattainable goal, as demonstrated by two previous FDA approvals
However, achieving regulatory approval of ananti-abuse opioid is not an unattainable goal for companies in this field. Thisis demonstrated by the FDA's August 2009 decision to approve Embeda (morphineand naltrexone, King Pharmaceuticals). Embeda is designed to work such that, ifthe 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 has been designed to discourage misuseand abuse potential.
Opioids market is set to grow
Despite consisting of numerous reformulations ofold drugs, the opioids market in the US grew by 9.3% between 2008 and 2009, toreach sales of $7.6 billion in 2009 (IMS Health. Datamonitor forecasts the total opioids market across the seven majorpharmaceutical markets (US, Japan, France, Germany, Italy, Spain and the UK) togrow as the result of the launch of anti-abuse technologies.
Development of anti-abuse opioids represents a keyopportunity for Pharma companies
There is growing concern surrounding the risk ofdivergence associated with opioid drugs. In particular, abuse and misuse hasbecome an increasingly recognized problem associated with opioids in the US andPurdue Pharma's Oxycontin (oxycodone) is frequently identified as a drug thatis being sold on the black market and abused. In light of this growing concern,Datamonitor believes that the development of anti-abuse opioids represents akey opportunity for companies in this market. The US FDA regards thedevelopment of anti-abuse opioids as an issue of high importance, as reflectedin the agency's decision to grant priority review designation to two suchproducts in 2008; Pain Therapeutics and King Pharmaceuticals Remoxy (oxycodone)and Alpharma's Embeda (naltrexone).
