ATLANTA--(BUSINESS WIRE)--Pharmaceutical innovator Galt Pharmaceuticals announced a new drug approval to offer a non-opioid, non-controlled, non-addictive alternative for healthcare providers to manage patients suffering from pain. On July 8, 2020 the U.S. Food and Drug Administration approved the company’s Supplemental Abbreviated New Drug Application for Orphengesic Forte, over two months ahead of the scheduled goal date.
“This is a big win in the fight against the U.S. opioid epidemic and the FDA’s swift early action confirms the seriousness of the issue,” said CEO and co-founder Barry Patel, Pharm.D. “Orphengesic Forte is a proven safer pain management alternative healthcare providers can consider before prescribing an opioid.”
Orphengesic Forte is indicated for the relief of mild to moderate pain of acute musculoskeletal disorders, paired with rest, physical therapy and other measures.
“The medical community is in great need of alternative therapeutic options to treat pain and Orphengesic Forte helps to meet that need because pain is very personal,” said Tapan Daftari, M.D., an orthopedic surgeon with Resurgens Orthopedics.
The Centers for Disease Control & Prevention reports 20% of U.S. adults are affected by chronic pain – one of the most common reasons adults seek medical care.
“Management of pain in the United States is a significant issue impacting quality of life for millions of adults,” said Galt Chairman and Co-Founder Wade Smith, Pharm.D. “Patients deserve more options from the best health care system in the world and that’s why we’re committed to expanding our portfolio with more pain medications in 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.
Galt is the first and only pharmaceutical company to create a unique pharmaceutical franchise or “Phranchise” concept that moves product representation away from corporate headquarters into local communities. Phranchises provide education to local healthcare providers while Galt manages functions such as drug research, regulatory approval, compliance and supply chain.
Learn more at www.GaltRX.com.
About Orphengesic Forte
INDICATIONS AND USAGE
Orphengesic Forte (Orphenadrine Citrate, Aspirin and Caffeine 50 mg/ 770 mg/60 mg) Tablets are indicated in:
1. Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders.
2. The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphengesic Forte Tablets do not directly relax tense muscles in man.
IMPORTANT SAFETY INFORMATION (ISI)
Contraindications
Orphengesic Forte is contraindicated in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy, obstructions at the bladder neck, myasthenia gravis, hypersensitivity to the drug, and known sensitivities to aspirin or caffeine.
Warnings and Precautions
- Orphengesic Forte is not recommended in patients with chicken pox, influenza, or flu symptoms due to the possible development of Reye’s Syndrome. Reye’s Syndrome is possibly associated with the use of aspirin.
- Patients should be cautioned on possible impairment of the ability to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle.
- Aspirin should be used with extreme caution in the presence of peptic ulcers and coagulation.
- Safety of use of Orphengesic Forte in pregnancy, during lactation, or in the child-bearing age has not been established; the potential benefits should be weighed against the possible hazard to mother and child.
- The safe and effective use in children has not been established; Usage in children under 12 is not recommended.
- Confusion, anxiety, and tremors have been reported with concomitant propoxyphene and orphenadrine.
- Safety of continuous long term therapy with Orphengesic Forte has not been established; If prescribed for prolonged use, periodic monitoring of blood, urine, and liver function values is recommended.
Adverse Reactions
The side effects of Orphengesic Forte are those seen with aspirin and caffeine or those usually associated with mild anti-cholinergic agents. These may include tachycardia, palpitation, urinary hesitancy or retention, dry mouth, blurred vision, dilation of the pupil, increased intraocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, and drowsiness.
For more safety information and the complete list of adverse reactions, please see the Full Prescribing Information for Orphengesic Forte.