CUMBERLAND, R.I.--(BUSINESS WIRE)--Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that it has submitted a proposal to the US Food and Drug Administration (FDA) for a Phase III pivotal trial of COL-003 under the Special Protocol Assessment (SPA) process. The SPA process allows for official FDA evaluation of the clinical protocol of a Phase III clinical trial intended to form the primary basis for an efficacy claim and provides trial sponsors with a binding written agreement that the design and analysis of the trial are adequate to support the submission of a marketing application if the trial is performed in accordance with the SPA.
