The New Drug Application (NDA) by Watson Pharmaceuticals, Inc., for a six-month formulation of Trelstar (triptorelin pamoate) has been accepted for filing. Triptorelin is a luteinizing hormone-releasing hormone (LHRH) agonist for the palliative treatment of advanced prostate cancer.
The sustained-release formulation of the drug is designed to suppress testosterone production over a six-month period.
“This Trelstar formulation requires only one injection every 24 weeks and showed comparable efficacy and safety with our marketed Trelstar one- and three-month formulations,” said Paul Bisaro, Watson’s president and chief executive officer.
“It should be a welcome alternative for men and their physicians and will be a significant addition to our expanding urology portfolio.” The company expects the FDA to take action on the NDA in the third quarter of 2009.