FDA Decision Calendar: Pain Drug Delays Likely

The first table features an updated calendar of 86 expected FDA new product decisions while the second table highlights 89 pending clinical trial result estimates and pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars.

New FDA Decision Calendar Entries:

1.) Biogen Idec (BIIB) and Genentech (DNA) have a PDUFA decision date of 7/15/09 for a pending sBLA to expand the use of Rituxan (rituximab) to include the treatment of moderate to severe rheumatoid arthritis in patients who have an inadequate response to one/more first-line treatments known as disease-modifying anti-rheumatic drugs (DMARDs).

2.) Johnson & Johnson (JNJ): JNJ has a PDUFA date of 8/4/09 for its complete response to an August 2008 approvable ruling for Paliperidone (Invega) Once-Monthly Injection for the treatment of schizophrenia. JNJ also filed a pair of sNDA's to expand the use of Invega E.R. Tablets to include the treatment schizoaffective disorder as both monotherapy and in combination with other treatments for the condition.

A Painful Ruling by the FDA:

The FDA issued a statement today directed at drug makers which market the strongest types of painkillers – classified as opiates, narcotics, and DEA Class 2 Controlled Substances. The FDA wants pain drug makers to play a larger role in stemming abuse and diversion issues amidst concern about the rising incidence of overdose deaths, abuse, misuse, and diversion associated with opiates such as Duragesic (fentanyl patches), OxyContin, and similar drugs.

King Pharma (KG) is most affected by the FDA's statement since it is developing Remoxy and Embeda as two opiate painkillers designed to reduce the risk of abuse and misuse. Pain Therapeutics (PTIE) and KG received a complete response for Remoxy in December while KG acquired Embeda with the Alpharma acquisition, but the FDA has not issued a decision on the latter pending NDA.

BioDelivery Sciences (BDSI) also submitted a complete response for an opiate painkiller on 12/15/08, but Onsolis is targeted for hospital use in the treatment of breakthrough pain in cancer patients so it should not be affected by the ruling today. While King's two pending applications are abuse-resistant forms of opiates; they will be marketed to a much wider population compared to Onsolis and will likely face further delays given the FDA's statement today.

Comments

[RRSPSRME:]

As a related stock to this article would ACUR not be included in that list? They currently have a NDA in front of the FDA.

Feb 18 07:15 AM