Supprelin LA was evaluated as a 12-month implant for treating central precocious puberty (CPP), or the early onset of puberty. The multi-center, open-label study involved 36 patients, primarily female, who ranged in age from four to 11 years.
Valera said it anticipates finalizing documents for the submission of a new drug application (NDA) to the FDA by the end of 2006. Meanwhile, the company plans to present interim data at the 2006 annual meeting of the Pediatric Academic Societies.
CPP, which is more prevalent in girls, is characterized by the premature development of secondary sexual characteristics due to an increase in secretion of the sex hormones. Additionally, if left untreated, the disorder limits a child from attaining full adult height, thus, resulting in short stature.
Supprelin LA would target a US therapy market currently estimated by Valera to be worth over $75 million annually. This market is dominated by Lupron Depot-PED (leuprolide acetate for depot suspension) produced by TAP Pharmaceutical Products, which involves intramuscular injections of leuprolide administered every 4 weeks. This contrasts to Supprelin LA, which is designed to provide a continuous twelve-month treatment.
The implant would administer a controlled dose of histrelin acetate, which was previously approved by the FDA and marketed during the 1990’s, under the brand name Supprelin, as a daily injection for treating CPP. In February 2006, Valera acquired the Supprelin brand name for use with its long-acting implant.