CUMBERLAND, R.I.--(BUSINESS WIRE)--Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that the FDA has accepted its Investigational New Drug (“IND”) filing for its patented combination product for the treatment of allergic rhinitis. The company also announced that it has initiated enrollment in a placebo controlled, multi-center “Proof of Concept” (POC) trial. After meeting with the FDA and receiving guidance on the basis of approval, Collegium has established a clinical plan aimed at achieving regulatory approval and has designed the protocol for its phase 3 pivotal trials. The POC trial is designed to investigate the potential of the combination product to achieve the desired endpoints in the pivotal trials.
