Connetics Corporation (CNCT) To Resume Extina Development With New Phase III Trial
10/19/2005 5:08:45 PM
PALO ALTO, Calif.--(BUSINESS WIRE)--June 8, 2005--Connetics Corporation (Nasdaq:CNCT), a specialty pharmaceutical company focused on dermatology, announced today that after additional discussions with the FDA it will resume development of Extina(R), an investigational new drug formulation of 2% ketoconazole for the treatment of seborrheic dermatitis. The Company received a non-approvable letter for Extina in November 2004 due to insufficient clinical data. As a result of meetings between Connetics and FDA officials regarding requirements for the Extina NDA, Connetics will recommence development by initiating a final Phase III trial intended to demonstrate that Extina is superior to placebo foam.
The Phase III trial is expected to commence in the third quarter of 2005 which should position Connetics to resubmit the NDA for Extina to the FDA by the end of 2006 with an anticipated review time of up to six months. Incremental development expenses associated with Extina for the second half of 2005 are estimated to be approximately $1.0 million.