FDA Roundup: This week’s FDA approvals and updates (July 18-July 24)
FDA approves non-opioid pain medication
The U.S. Food and Drug Administration has approved Orphengesic Forte (orphenadrine citrate, aspirin, caffeine tablets; Galt Pharmaceutical), a non-opioid alternative, for the treatment of mild to moderate pain of acute musculoskeletal disorders, paired with rest, physical therapy and other measures.
“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, PharmD, in a press release. “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.”
Read the full press release here.
FDA approves treatment for neuropathic pain associated with diabetic peripheral neuropathy
The U.S. Food and Drug Administration has approved Qutenza (capsaicin; Averitas Pharma, Inc) 8% patch for the treatment of neuropathic pain associated with diabetic peripheral neuropathy of the feet in adults.
The patch provides a topical, non-systemic, non-opioid pain treatment. It is the first treatment of its kind to deliver prescription strength capsaicin directly into the skin.
“Pain associated with diabetic neuropathy is an extremely challenging condition to diagnose, treat and manage effectively, which has a significant quality of life impact for many patients,” said David M. Simpson, MD, principal investigator and Professor of Neurology at the Icahn School of Medicine at Mount Sinai, in a press release. “In addition, patients are dissatisfied with unresolved pain and the side effects associated with current systemic treatments.”
In 2009, capsaicin was approved for the management of neuropathic pain associated with postherpetic neuralgia.
Read the full press release here.
FDA approves Xywav for narcolepsy
The U.S. Food and Drug Administration approved Xywav (calcium, magnesium, potassium, and sodium oxybates; Jazz Pharmaceuticals) oral solution for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
Approval was based on a Phase 3 double-blind, placebo-controlled, randomized-withdrawal, multicenter study that demonstrated the efficacy and safety of Xywav in the treatment of cataplexy and EDS in patients with narcolepsy. I
“Based on the efficacy demonstrated in the clinical program, the approval of Xywav is important for people living with cataplexy or EDS associated with narcolepsy. Xywav makes it possible for patients to have a lower-sodium oxybate treatment option. This may help patients taking sodium oxybate better align with daily sodium intake recommendations including those by the American Heart Association,4” said Richard K. Bogan, MD, FCCP, FAASM, associate clinical professor at the University of South Carolina School of Medicine, a medical officer at SleepMed in Columbia, SC and lead investigator of the Phase 3 study in a press release. “The average American consumes too much sodium. Excess sodium intake has been linked with increases in blood pressure, hypertension, stroke, and other cardiovascular disease.”
Read the full press release here.
FDA approves cream for plaque psoriasis
The U.S. Food and Drug Administration has approved calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064% (Wynzora cream; MC2 Therapeutics) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older..
Approval is based on a phase 3 clinical trial of 794 patients which showed at least a 2-grade improvement from baseline in Physician Global Assessment to “clear” or “almost clear” at 8 weeks in patients treated with Wynzora cream.
“Wynzora Cream is a novel topical treatment for plaque psoriasis which offers a unique combination of high efficacy, favorable safety and excellent treatment convenience in a single product,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, and lead principal investigator in the study, in a press release.
Read the full press release here.
