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Article: Collegium Pharmaceutical Inc., Announces FDA Acceptance of IND for Novel Combination Allergic Rhinitis Product.
- Article from:
- Business Wire
- Article date:
- October 4, 2006
CopyrightCOPYRIGHT 2006 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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- Announces Initiation of Patient Enrollment in Phase 2 Trial-
CUMBERLAND, R.I. -- 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 ...