Valera submits NDA for puberty-delaying drug

By Elaine Rigoli

Tampa, Fla., July 6 - Valera Pharmaceuticals, Inc. has submitted a New Drug Application to the Food and Drug Administration for Supprelin-LA, a 12-month implant for central precocious puberty, or the early onset of puberty in children.

Supprelin-LA provides the continuous 12-month administration of a controlled-dose of histrelin, a potent synthetic nonapeptide agonist of naturally occurring gonadotropin-releasing hormone (GnRH).

The standard of care of central precocious puberty involves the use of such GnRH agonists to suppress hormonal production to delay the onset of puberty, according to a news release.

The multi-center, open-label phase 3 study of Supprelin-LA, which is the basis of the NDA submission, involved 36 patients ranging in age from four to 11 years.

Sixteen children had received GnRH therapy prior to enrollment while the remaining 20 were naive to treatment, the release said.

The subcutaneous implant was inserted into the inner aspect of the upper arm. Primary endpoints were hormonal suppression below pubertal levels and continued suppression upon challenge with gonadotropin-releasing hormone.

Supprelin, as a daily injection, was previously approved by the FDA and marketed in the 1990s to treat central precocious puberty. Valera acquired the rights to the brand name earlier this year.

Valera is a specialty pharmaceutical company based in Cranbury, N.J.

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