King will have input from an FDA advisory committee before resubmitting its immediate-release oxycodone formulation Acurox and the company hopes that will translate into a relatively rapid approval.

"We are anticipating an FDA advisory committee for Acurox sometime in spring, but the date has yet to be announced," CEO Brian Markison said during an interview at the J.P. Morgan Health Care conference in San Francisco Jan. 13. "We think that having a successful advisory committee meeting will help us be able to quickly resubmit the NDA."

Acurox, which combines oxycodone with a subtherapeutic dose of niacin, is intended to discourage abuse by triggering an aversion among users who take excessive numbers of pills; someone who takes multiple doses of Acurox at once is likely to experience the unpleasant flushing reaction associated with niacin.

However, like most therapies in the opioid class, the regulatory process hasn't been smooth. King and its development partner Acura received a "complete response" letter in July (Also see "Business In Brief" - Pink Sheet, 6 July, 2009.).

King met with FDA in September to discuss the complete response letter, and the decision to take it to an advisory committee followed. However, it does not appear that King is formally appealing the complete response letter.

FDA tentatively has scheduled a meeting of the Anesthetic and Life Support Drugs Advisory Committee April 22-23; that is the likely target date to discuss Acurox.

King expects an up-or-down vote on the approvability of the application, even though it is not technically pending for approval. The discussion is likely to focus on standards for "aversive" formulations in general: reaching agreement on how to determine whether the Acurox formulation does in fact trigger aversion, and if it does, whether it is sufficient to suggest a reduced abuse liability.

"FDA is looking for its advisors to help the agency interpret the data that will be in the resubmission," Chief Science Officer Eric Carter explained. "Given that the science of abuse liability studies is still emerging, the division director determined that an advisory committee was the appropriate venue to review the Acurox data."

"The expectation is that FDA will ask the advisory committee whether Acurox should be approved or not, and if the committee votes in favor of approval then the resubmission is quite honestly a relatively simple resubmission. There's not much, and hopefully they will review it relatively quickly."

A Big Year For King At FDA

The Acurox resubmission is only one of several important FDA-related milestones King anticipates in 2010.

The first will be approval of its launch materials for the long-acting opioid formulation Embeda , which combines morphine sulfate with naltrexone (the latter ingredient intended to block the effect of the morphine if the sustained-release pill is crushed).

Embeda was approved by FDA in August, but the company received a warning letter from the agency in response to video news releases announcing the launch. That in turn has meant a delay in rolling out a full launch campaign (Also see "Embeda Uptake In Primary Care Depends On FDA Clearing Marketing Materials, King Says" - Pink Sheet, 5 November, 2009.).

"We met with [FDA's Division of Drug Marketing Advertising and Communication] just before Christmas, and I think both sides fully understand each other and are taking the appropriate steps to address the issues," Carter said.

The letter followed "a mistake on our part," Carter added. "We let video news releases go through that we should never have approved. The materials cited...were not a deliberate attempt to mislead, and were nothing other than the result of inadvertent internal errors that we made."

And, Markison said, the launch of Embeda is proceeding nicely, all things considered. "Despite limited materials for our field team initially, including an annotated package insert for the first two months post-approval, we have seen that the physician receptivity has been terrific, and that managed care acceptance has been quite positive. We believe now that we are in the New Year that we will see a steady build of prescription growth week over week."

King also is planning to resubmit its application for a long-acting, abuse-resistant form of oxycodone ( Remoxy), which also received a "complete response" letter at the end of 2008 (Also see "Now Who Needs a Painkiller? King and Pain Therapeutics Face a Remoxy Setback" - Pink Sheet, 7 July, 2009.).

"The Remoxy resubmission is going to be a bit more voluminous than Acurox," Markison noted. "We are excited about the way those plans are coming together. Everything remains on track. And we think that the business case for Remoxy and the value proposition remains every bit as strong as it did when we first licensed the product."

King expects Remoxy also will go before an advisory committee in 2010.

Last but not least, King's Carter is working on behalf of all long-acting opioid manufacturers as FDA works on developing a class-wide REMS. FDA plans another meeting on that project this spring (Also see "Opioid Risk Management: FDA Not Impressed With Industry Working Group's Proposals" - Pink Sheet, 4 December, 2009.).

-Michael McCaughan (m.mccaughan@elsevier.com)

King Expects Acurox Committee In April: What Are The Standards For Aversion-Based Abuse-Resistance?

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