Debiopharm Group (Debiopharm) has announced that the New Drug Application (NDA) for the 6 month formulation of Trelstar (triptorelin pamoate) has been accepted for filing by the US Food and Drug Administration (FDA).
Trelstar is a luteinizing hormone releasing hormone (LHRH) agonist for the treatment of locally advanced or metastatic prostate cancer.
Rolland-Yves Mauvernay, president and founder of Debiopharm Group said: “Last September we announced the filing of the product with the European Agencies, under the name Decapeptyl. We are proud to have accomplished the simultaneous filings of Trelstar and Decapeptyl in both the US and Europe, it’s a great achievement for us.”
Once approved, Trelstar will be commercialised in the US by Watson Pharmaceuticals Inc.
“This demonstrates our ability to work effectively not only with different regulatory agencies, but also different partners. Furthermore, our FDA inspected research development and production facility, Debio RP, will produce both products for global distribution,” he continued.
The NDA for the 6 month formulation of Trelstar is supported by data from a phase III study on the efficacy and safety of two consecutive injections of triptorelin 6-month formulation in 120 patients with advanced prostate cancer. The results showed that 97.5% of patients achieved castrate levels of serum testosterone 28 days after the first injection and that 93% of the patients maintained serum testosterone levels below castrate level (defined as < 1.735 nmol/L or 50 ng/dL) from week 8 to 48.
These efficacy results are similar to those obtained previously with repeated administrations of the 1- and 3-month formulations of Trelstar, which are already marketed by Watson Pharmaceuticals, Inc.