Collegium Pharmaceutical Inc., Announces FDA Acceptance of IND for Novel Combination Allergic Rhinitis Product.- Announces Initiation of Patient Enrollment in Phase 2 Trial- CUMBERLAND, R.I. -- Collegium col·le·gi·um n. pl. col·le·gi·a or col·le·gi·ums 1. An executive council or committee of equally empowered members, especially one supervising an industry, commissariat, or other organization in the Soviet Union. Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has accepted its Investigational New Drug ("IND") filing for its patented combination product for the treatment of allergic rhinitis Allergic Rhinitis Definition Allergic rhinitis, more commonly referred to as hay fever, is an inflammation of the nasal passages caused by allergic reaction to airborne substances. . The company also announced that it has initiated enrollment in a placebo controlled, multi-center "Proof of Concept" (POC (Proof Of Concept) See PoC exploit. POC - Point Of Contact ) 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. In the United States, allergic rhinitis affects approximately 40 million people, according to the American Academy of Allergy, Asthma, and Immunology The American Academy of Allergy, Asthma, and Immunology (AAAAI) is the largest medical specialty organization in the United States. It deals with issues of allergy at all levels, including asthma and immunology. . Annual sales of allergic rhinitis products are currently estimated at greater than $4 billion per year in the U.S. Antihistamine antihistamine (ăn'tĭhĭs`təmēn), any one of a group of compounds having various chemical structures and characterized by the ability to antagonize the effects of histamine. products comprise a significant sector of this market. Antihistamines Antihistamines Definition Antihistamines are drugs that block the action of histamine (a compound released in allergic inflammatory reactions) at the H1 that are currently available for the treatment of allergic rhinitis include the older antihistamines which tend to have a sedating effect, such as diphenhydramine diphenhydramine /di·phen·hy·dra·mine/ (di?fen-hi´drah-men) a potent antihistamine, used as the hydrochloride salt in the treatment of allergic symptoms and for its anticholinergic, antitussive, antiemetic, antivertigo, and antidyskinetic (e.g. Benadryl[R]), and the newer antihistamines which are considered less sedating, such as loratadine (e.g. Claritin[R]). Clinicians estimate that 20-40% of patients with allergic rhinitis have worsening symptoms at bedtime, which can cause difficulties sleeping and incomplete treatment response throughout the day. Currently, there are no 'once a day' products on the market in the U.S. that capitalize on the unique benefits of both types of antihistamine in a single formulation. Collegium's combination product incorporates both a sedating and non-sedating antihistamine in a proprietary formulation that is the subject of a U.S. patent. The POC Study is currently enrolling at four (4) sites in the U.S. The study is expected to be completed in 2006, with results available in early 2007. Following the successful completion of this study, Collegium expects to commence phase 3 trials with its proprietary formulation and to file the NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any after the completion of all regulatory requirements. "We are very pleased to move this product into the clinic, and with a clear understanding of the regulatory requirements necessary for its approval" said Michael Heffernan, R.Ph., President, Collegium Pharmaceutical. "This product has the potential to address a large unmet patient need in the treatment of allergic rhinitis. The once a day treatment associated with this product allows patients to take full advantage of the beneficial effects of a sedating antihistamine at bedtime in addition to the benefits of a non-sedating antihistamine during the course of the day." About Collegium Pharmaceutical Collegium Pharmaceutical, Inc. is a privately held specialty pharmaceutical company focused on the development of proprietary, late stage pharmaceutical products. These products target market opportunities through product improvement and line extension strategies protected by intellectual property (IP). Collegium applies customized pharmaceutical formulations and IP strategies to active ingredients that have been shown to be safe and effective, creating a portfolio of improved pharmaceutical products with potentially less development risk and shorter times to market. Collegium uses its broad expertise in IP development, drug formulation, manufacturing, basic science (chemistry, biology, bioengineering bioengineering Application of engineering principles and equipment to biology and medicine. It includes the development and fabrication of life-support systems for underwater and space exploration, devices for medical treatment (see ), marketing and clinical trials management to identify and execute product opportunities for itself and its partners. For more information, visit the Company's website at www.collegiumpharma.com |
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