Additionally, the Committees voted 12 to 5 that the drug should be labeled as an abuse-deterrent product by the nasal route of abuse.
The Committees also voted 10 to 7 that the drug should not be labeled as an abuse-deterrent product by the intravenous route of abuse.
SpecGx is advancing this reformulation of Roxicodone® (oxycodone hydrochloride tablets USP) with properties designed to deter intravenous and intranasal abuse under the company's 505(b)2 new drug application MNK-812. The company has been a leader for a number of years in delivering important solutions, including development of this technology, to reduce opioid misuse, abuse and diversion.
"We appreciate the Committees' thoughtful review and discussion of the potential benefits our new abuse-deterrent formulation drug can bring in helping to mitigate opioid abuse and misuse," said
The role of the Committees is to provide recommendations to the
The company has for years been at the forefront of preventing prescription drug diversion and abuse, and has invested millions of dollars in a multi-pronged program to address opioid abuse. In addition to abuse-deterrent technology, those efforts include the purchase and donation of nearly two million drug disposal pouches, and working with policymakers, community leaders, law enforcement and industry partners to ensure the responsible use of pain medication and preventing unused medications from ending up in the wrong hands. These efforts will continue to be supported.
Please click here for more information about these efforts.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning MNK-812 including expectations with regard to future regulatory actions and potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; future commercialization efforts; and other risks identified and described in more detail in the "Risk Factors" section of
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