Progenics Pharmaceuticals, Inc. (PGNX) and Salix Pharmaceuticals, Inc. (SLXP) were up 8.49% and 2.68%, respectively after the companies announced that the FDA is ready to approve Relistor (subcutaneous injection) on the basis of data submitted in the supplemental new drug application (sNDA).
The companies are looking to get Relistor approved for the treatment of opioid-induced constipation (:OIC) in patients taking opioids for chronic non-cancer pain. Relistor is a peripherally acting mu-opioid receptor antagonist (:PAMORA). The drug is already approved for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.
We remind investors that the FDA had issued a complete response letter (CRL) for the Relistor sNDA.
The FDA has requested the companies to submit certain information related to Relistor including proposed product labeling. Salix intends to submit the information over the next several weeks. The FDA has asked the company to discuss its development plans with the GI division regarding oral Relistor.
As per the new ruling, no cardiovascular outcomes study, one-year controlled study or other pre-approval safety study is required for the approval of Relistor for OIC in chronic non-cancer pain patients. The ruling is a major positive as additional cardiovascular outcomes studies would have increased the cost of developing Relistor. This could have also resulted in a delay in the approval process.
Last month, the majority of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (:AADPAC) members had voted that cardiovascular outcomes studies are not needed for the PAMORA class of drugs.
AstraZeneca (AZN) is also looking to get its naloxegol (proposed brand name: Movantik) for OIC in patients with chronic non-cancer pain. The FDA is expected to render a final decision on the approval status of naloxegol by Sep 16, 2014.
Salix and Progenics currently carry a Zacks Rank #1 (Strong Buy) and Zacks Rank #3 (Hold) respectively. Currently, Mallinckrodt (MNK) also looks attractive with a Zacks Rank #1.