Progenics Pharmaceuticals, Inc.
Salix Pharmaceuticals, Inc.
) 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
) 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,
) also looks attractive with a Zacks Rank #1.
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