FDA Approves Non-Opioid Analgesic for Mild to Moderate Pain

FDA, Medicare Set-Aside Blog, Rx/Pharmacy on August 3, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

On July 16th, the FDA approved Orphengesic Forte, a non-opioid combination analgesic for the treatment of mild to moderate pain associated with acute musculoskeletal conditions. The FDA’s approval came earlier than expected, which many have viewed as a reinforcement of the FDA’s commitment to do everything in its power to combat the opioid epidemic. Orphengesic Forte is the FDA’s second approval in 2020 for a non-opioid analgesic. In February of this year, the FDA approved Anjeso™, which is a formulation of meloxicam for intravenous administration. 

In actuality, Orphengesic Forte is not a new drug but rather, a resurrection of an old drug. Orphengesic Forte was previously manufactured by Par Pharmaceuticals, but was voluntarily recalled from the market many years ago. Each Orphengesic Forte tablet contains 50mg of orphenadrine, 770mg of aspirin and 60mg of caffeine. Orphengesic Forte is recommended to be used in combination with other pain relief measures such as rest and physical therapy. Many are hopeful that Orphengesic Forte will create a viable alternative to opioid therapy in patients with mild to moderate pain of musculoskeletal origin, and for this reason may appear in Medicare Set-Asides in the future. Adults and children age 12 and older may use one-half to one tablet three to four times per day, as needed for mild to moderate pain or discomfort. Use of Orphengesic Forte has not been studied in children under the age of 12. As with other drugs, Orphengesic Forte is not appropriate for every patient. In addition to children under the age of 12, the drug should be avoided in patients with glaucoma, myasthenia gravis and certain types of obstructions in the stomach, small intestine and bladder. Patients with sensitivity to either aspirin or caffeine should also avoid the use of Orphengesic Forte. 

Galt Pharmaceuticals, the manufacturer of Orphengesic Forte, expects to make the drug available in mid-August. Pricing information is not available at this time. As we learn more about this novel therapy, we’ll continue to post updates here, and advise of any potential impact to claims.