Earlier this week, King Pharmaceuticals, Inc. (KG) announced the launch of Embeda, which recently received U.S. Food and Drug Administration (FDA) approval for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Embeda, which is the first FDA-approved long-acting opioid designed to reduce drug liking and euphoria when tampered with by crushing or chewing, will be available in six dosage strengths. As per the requirement of the FDA, the company has also implemented a Risk Evaluation and Mitigation Strategy (REMS) under which patients and providers will be informed about the potential for abuse, misuse, overdose, and addiction of Embeda and about the safe use of the opioid.
The approval and launch of Embeda is a significant milestone for King which recently faced regulatory setbacks for two other pain management candidates, Remoxy and Acurox. With a significant head-start over other abuse-deterrent products which are being developed, Embeda’s launch should help establish King’s position as a leader in the abuse deterrent opioid market.
King is looking to strengthen its position in the pain management market and has several products in development for the management of pain including ketoprofen in tranfersome gel, Eladur, and oxycodone NT. King expects to resubmit its new drug application (NDA) for Remoxy in mid-2010.
The company has an agreement with Pain Therapeutics (PTIE) for the development and commercialization of Remoxy, which has been developed using Durect Corp.’s (DRRX) ORADUR technology. Meanwhile, Acurox, which is being developed with Acura Pharmaceuticals, Inc. (ACUR), will be reviewed by an advisory panel of the FDA later this year.
We currently have an Underperform rating on King. While the approval and launch of Embeda is good news for the company, we remain concerned about the declining prescription trends for key products and the possibility of Skelaxin facing generics later this year.
Read the full analyst report on “KG”
Read the full analyst report on “ACUR”
Read the full analyst report on “PTIE”
Read the full analyst report on “DRRX”
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