Regulatory decisions are highly awaited events in the pharma/biotech sector. A positive decision may result in significant stock price appreciation.
Earlier in the week, the FDA has approved Salix Pharmaceuticals, Inc. (SLXP) and Progenics Pharmaceuticals, Inc.’s (PGNX) Relistor subcutaneous injection (12 mg/0.6ml) for the treatment of opioid-induced constipation (OIC) in patients taking opioids for chronic non-cancer pain.
Results from a phase III study on Relistor in patients suffering from OIC in chronic non-cancer pain revealed that a larger number of patients under Relistor showed three or more spontaneous bowel movements per week during the four-week period compared to those under placebo.
Relistor is a peripherally acting mu-opioid receptor antagonist (PAMORA). The drug is already approved in the U.S. for the treatment of OIC in patients with advanced illness who are under palliative care, when response to laxative therapy has not been sufficient. Relistor is also approved in several countries around the globe including the EU for the above indication.
Our Take
Relistor’s approval for the new indication comes as a huge relief to Salix as the path was far from smooth. We remind investors that Salix had received a complete response letter (CRL) from the FDA in Jul 2012 for its sNDA on Relistor. In the CRL, the FDA had asked for additional data. Needless to say, the new indication will boost the drug’s sales.
Currently, Sucampo Pharmaceuticals, Inc.’s (SCMP) Amitiza is an approved treatment for OIC in patients with chronic pain.
Investors in the healthcare sector can also consider stocks like Gilead Sciences (GILD).
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