The USA's Valera Pharmaceuticals says it has successfully completed the active clinical portion of a Phase III study of Supprelin LA, a 12-month implant for early-onset puberty.
This multicenter, open-label study involved 36 patients, primarily female, who ranged in age from four to 11 years. Valera said that, in line with its previously-stated milestone goal for the submission of a New Drug Application to the US regulators, it anticipates finalizing the necessary documentation by the end of the second quarter of the year. The interim data will be presented at the upcoming annual meeting of the Pediatric Academic Societies to be held in San Francisco, California.
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