Watson Pharmaceuticals, Inc. (NYSE: WPI), today announced the U.S. Food and Drug Administration (FDA) approval of TRELSTAR® 22.5 mg (triptorelin pamoate for injectable suspension), a new twice-yearly formulation of TRELSTAR®, a proven, simple and effective palliative treatment of advanced prostate cancer. With an anticipated May launch, TRELSTAR® 22.5 mg is the first and only six-month intramuscular (IM) GnRH agonist available for the palliative treatment of advanced prostate cancer. TRELSTAR® 22.5 mg is also the only six-month GnRH agonist that is stored at room temperature; no refrigeration is required.
TRELSTAR® 22.5 mg releases triptorelin pamoate, a gonadotropin releasing hormone (GnRH) agonist, over a prolonged period and, in turn, suppresses testosterone production for six months. Developed by Debiopharm Group and first approved in the U.S. in 2000, TRELSTAR® is indicated for the palliative treatment of advanced prostate cancer and is currently available in one-month (3.75 mg) and three-month (11.25 mg) forms. The new, longer-acting six-month formulation is designed to provide patients and physicians with a more convenient therapeutic option that is well tolerated and as effective.
TRELSTAR® is administered via the MIXJECT® delivery system, which utilizes a thin (21-gauge) needle, and thereby offers easy administration with low incidence of injection site pain. In fact, in the clinical trial, only 1.7% of patients reported injection site pain. Following administration, the MIXJECT® needle is captured to help comply with OSHA regulations.