Galt Pharmaceuticals Receives FDA Priority Review for Non-Controlled Pain Management Drug, Orphengesic Forte, an Opioid-Free Alternative for Patients

ATLANTA--(BUSINESS WIRE)-- Pharmaceutical industry innovator Galt Pharmaceuticals aims to give physicians and patients an opioid-free alternative for the management of pain. The company submitted a Supplemental Abbreviated New Drug Application to the U.S. Food and Drug Administration for Orphengesic Forte and has been provided a Priority Review goal date for approval by August 14, 2019.

“Healthcare providers simply need more choices as they look for non-controlled opioid free alternatives for pain management and our goal is to offer one more proven alternative before prescribing an opioid or controlled medication,” said Galt CEO and co-founder Barry Patel, Pharm.D.

In 2017, the U.S. Department of Health and Human Services declared the U.S. opioid epidemic a public health emergency. A surge in misuse and over prescribing of opioids led to 11.4 million people misusing prescription opioids alone in 2016. It is estimated that 47,600 people died from opioid overdoes in 2017. Further data shows an increase in opioid usage of 30 percent from July 2016 to September of 2017 across the United States.

“Our healthcare providers are challenged by meeting the individual patient needs in pain management, while trying to avoid using opioids and other controlled substances,” said Snehal Doshi, Pharm.D., VP of Pharmacy Services at one of Georgia’s largest health systems. “We absolutely need more choices for them to try and we are glad to see a proven analgesic coming to the market.”

Orphengesic Forte is an oral non-controlled combination muscle relaxant pain reliever. The oral tablets contain 50 mg of Orphenadrine Citrate, 770 mg of Aspirin and 60 mg of Caffeine. It is indicated for the relief of mild to moderate pain of acute musculoskeletal disorders, paired with rest and physical therapy.

“We strongly believe that we can reverse the opioid crisis in advancing better practices for pain management by continuing to bring non-opioid alternatives to market,” said Galt Chairman Wade Smith, Pharm.D. “Our portfolio will continue to expand with various other non-opioid pain medications in the coming years.”

About Galt Pharmaceuticals

Galt Pharmaceuticals has found a better way to enhance the quality of life of patients with products that answer unmet clinical needs, while creating life-changing opportunities for entrepreneurs, our employees and the individuals within the communities we serve.

Learn more at www.GaltRX.com.

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