King Pharmaceuticals remains confident that the FDA's upcoming public meeting to discuss implementing a class-wide Risk Evaluation and Mitigation Strategy for long-acting opioids will not deter approval for Embeda , its abuse-resistant oral morphine .

King CEO Brian Markison urged analysts to separate an anticipated Embeda approval from the upcoming REMS public meeting, set for May 27-28. "I don't really think that the two are related in any respect," he said during a first-quarter earnings call on May 11.

"I think the upcoming meeting ... is really more of an opportunity for the agency to get a lot of feedback on what they are proposing with regard to the [class-wide] REMS and I would really disassociate that from what we're actually going through ourselves," Markison continued.

Drug makers of long-acting and extended-release opioids have much at stake in the meeting, as FDA determines how best to implement class labeling for various products in the same therapeutic category.

The FDA will likely require a certification process for prescribers, pharmacists and other heath care providers, a strong patient education component, and prescriber-patient agreements, according to agency questions released in advance of the meeting (¹ Also see "Opioid Class REMS: FDA Wants Prescriber/Pharmacist Certification" - Pink Sheet, 17 April, 2009.).

In discussions specific to Embeda, FDA has offered clear recommendations and guidance about what should be included in the REMS, King execs maintained. King added Embeda, as well as the long-acting oxycodone formulation Remoxy, to its pipeline after acquiring Alpharma last December.

"I think the best way to describe [the REMS] at this time is to say that it's not unduly burdensome for the company," Markison said in response to questions. "And while we're still benching out some of the elephants and what it will look like, again it's something that we are well prepared to live with." An approval is anticipated "shortly" with a launch expected in 2009 (² Also see "King Confident Of Embeda Opioid Approval In 2009; REMS Is The Final Hurdle" - Pink Sheet, 2 March, 2009., p. 24).

Following talks with health care practitioners at the American Pain Society meeting, Cowen analysts predict that Embeda will see quick uptake in the market once launched.

"Pain specialists we spoke with are concerned about liability, and now are more willing and better equipped to assess and stratify patients by risk of abuse and modify treatment accordingly," the analysts said in a note. "They view tamper-resistant opioids as a critical component in the abuse-risk reduction plan, so predict relatively rapid adoption for Embeda."

But regardless of Embeda's approval date, the agency's finalized requirements for opioids will likely cause King, and other long-acting opioid drug makers, to modify and resubmit any existing REMS to FDA to ensure compliance.

King also must weigh the impact of a class-wide REMS on its long-acting oxycodone formulation Remoxy , awaiting an FDA decision.

King looks to submit Remoxy "complete response"

During the first quarter, King assumed full control of development activities for abuse-resistant Remoxy from Pain Therapeutics, and with it King also inherited an agency "complete response" letter for the product.

Pain Therapeutics received a "complete response" letter from FDA for Remoxy last December, asking for more data showing that the drug holds against common abuse techniques (³ [A#00700500008] p. 16).

King plans to discuss the letter with FDA in an early July meeting. "We are confident that this new date will not delay our resubmission," King execs said.

"When we come out of that meeting, we will have a better chance to give the Street some direction as to when we will be submitting the NDA and our response to the complete letter," Markison told analysts.

King also is awaiting FDA feedback on a "fairly complete" REMS submitted for Remoxy.

In addition, the firm's short-acting opioid Acurox, in development with Acura Pharmaceuticals, is expected to see FDA action June 30. King does not expect a REMS or an FDA advisory committee for the drug.

King sees revenues dip in Q1

Overall, King reports a slight decrease in total revenues for the first quarter at $429 million compared to $432 million the same quarter last year.

Generic competition for its most important drug, the antihypertensive Altace (ramipril), which went off patent in 2007, continues to impact sales, as well as acquisition charges.

Additionally, sales of the muscle skeletal relaxant, Skelaxin (mexaxalone), declined to $101 million for the quarter from $116 in 2008, mainly because of decreased promotional activities. Sales of Thrombin-JMI (thrombin) also were down to $47 million in Q1from $67 million during the first quarter 2008, primarily due to discounting and a decrease in product units sold.

King reports growing prescriptions for the pain product Flector Patch - also an Alpharma product - despite a slight decrease following the close of the acquisition. King notes that scripts for the Flector Patch reached "an all-time high" in March, according to IMS data, with more growth expected as the firm takes advantage of managed care opportunities.

- Carlene Olsen (c.olsen@elsevier.com)

FDA Class-Wide REMS Meeting Won’t Deter Embeda Approval, King Believes

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