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Collegium Pharmaceutical Announces Completion of Enrollment in Pivotal Phase 3 Clinical Study for Oxycodone DETERx(R), Its Lead Abuse Deterrent Development Program Amgen (AMGN)'s Heart Failure Drug Ivabradine Wins Fast Track Status From The FDA
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Food and Drug Administration (FDA) regarding Oxycodone DETERx its extended release (ER), abuse deterrent, oxycodone microsphere in capsule product. The purpose of the meeting was to discuss the non clinical, clinical and Chemistry, Manufacturing and Controls (CMC) development of Oxycodone DETERx and to agree on the submission requirements for the NDA submission under 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. Following the meeting, Collegium intends to proceed with its NDA submission as previously announced.
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product. and international patents and patent applications. Oxycodone DETERx is the first of a number of product candidates using the DETERx platform.
"We continue to work closely with the FDA and appreciate its guidance as we prepare for our NDA submission," said Michael Heffernan, CEO of Collegium. "The pre NDA meeting reinforced our understanding of the Agency's requirements for our submission and brings us one more important step closer to potentially gaining approval for Oxycodone DETERx We remain on track to file the NDA in Q4 2014 and due to our Fast Track Status anticipate a Priority Review."
multi particulate design is expected to enable patients with difficulty swallowing to open the capsule and to administer the contents sprinkled onto food, directly into the mouth, or via a feeding tube, while maintaining the ER properties of the product. The DETERx technology can be used with drugs that are commonly abused such as opioids and amphetamines, as well as drugs that have narrow therapeutic windows that would benefit from protection against misuse such as breaking, crushing, grinding, or dissolving the Omega Constellation Automatic
Collegium Pharmaceutical Inc Announces Successful Pre NDA Meeting With FDA For Oxycodone DETERx174 Its Extended Release Abuse Deterrent Omega Seamaster Strap Product For The
The DETERx drug delivery platform consists of a microsphere in capsule formulation. While developed primarily to provide abuse deterrent properties to protect against common methods of tampering such as chewing, crushing, insufflation and extraction for IV injection, the Omega Constellation Diamond Dial
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