U.S. FDA Accepts Regulatory Submission and Grants Priority Review for US WorldMeds' Lofexidine

LOUISVILLE, Ky., Nov. 21, 2017 /PRNewswire/ -- US WorldMeds today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of the New Drug Application (NDA) for lofexidine, an investigational product to mitigate symptoms associated with opioid withdrawal and facilitate completion of opioid discontinuation treatment. Priority Review is granted to submissions for medications that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. During lofexidine's development, the FDA granted it Fast Track Status, a process designed to facilitate and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The Prescription Drug User Fee Act (PDUFA) date for lofexidine occurs during the second quarter of 2018.

Lofexidine's NDA submission is supported by two randomized, double-blind, placebo-controlled clinical trials and several supporting studies to characterize the safety of the product in a total of more than 1,000 patients. The product's development also involved an extensive clinical pharmacology program, including studies to investigate concomitant administration of lofexidine with methadone, buprenorphine and naltrexone.  

"The symptoms of withdrawal are agonizing and present a significant barrier to successful opioid discontinuation," said Mark Pirner, M.D., Ph.D., senior medical director, clinical research. "Opioid withdrawal is an important step that everyone at risk of physical dependence or addiction to opioids must face in their journey to discontinue opioids or bridge to other treatment and recovery steps. The FDA's decision to grant Priority Review to our lofexidine NDA highlights the critical role withdrawal management plays in the urgent need to address opioid abuse and misuse."

About Opioid Withdrawal
Opioids lower norepinephrine, a brain chemical that supports vital functions like respiration and consciousness. With repeated opioid use the brain establishes a new equilibrium by increasing compensatory norepinephrine production in order to maintain normal functioning. When an opioid is removed or its dose significantly reduced, the brain's increased norepinephrine levels are no longer offset by the presence of the opioids. This results in a norepinephrine surge that produces the acute, and painful symptoms of withdrawal. 

About Lofexidine
Lofexidine, an oral tablet, is a selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine. In clinical trials, lofexidine significantly reduced the severity of withdrawal symptoms compared to placebo as reported by patients experiencing opioid withdrawal. This potential new treatment is in development for the mitigation of symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation treatment. Lofexidine is not currently approved in the United States.

About US WorldMeds
US WorldMeds is a specialty pharmaceutical company whose treatment options are making a difference in the lives of the patients and communities it serves. US WorldMeds takes an agile and personal approach to pharmaceuticals – pioneering research and product development in therapeutic areas that desperately need new solutions. Headquartered in Louisville, Kentucky, US WorldMeds has global presence and more than 15 years of experience in the development, licensure and commercialization of unique products. For more information about US WorldMeds, visit http://www.usworldmeds.com/. Follow us on Twitter and on LinkedIn.

SOURCE US WorldMeds

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