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Regulatory Focus™ > News Articles > 2020 > 7 > FDA Approvals Roundup: Xywav, Qutenza, Orphengesic
FDA Approvals Roundup: Xywav, Qutenza, Orphengesic
Posted 22 July 2020 | By Renee Matthews
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approval
Xywav gets the nod as a low-sodium option for narcolepsy
Jazz Pharmaceuticals' Xywav (calcium, magnesium, potassium, and sodium oxybates oral solution) has been approved as a therapy for cataplexy or excessive daytime sleepiness in children aged 7 years or older and adults who have narcolepsy, a chronic and debilitating neurologic condition for which there is no cure.
The therapy contains 92% less sodium than Xyrem (sodium oxybate), which was approved in 2002 and has been the standard of care for these patients. Xyrem carries warnings about sodium content, but Xywav does not.
Xywav , like Xyrem,does have boxed warnings for central nervous system depression and abuse and misuse. It will therefore be available only through a restricted program under a Risk Evaluation and Mitigation Strategy the company plans to implement. Xywav has also been designated a Schedule III medicine by the US Drug Enforcement Agency because of its moderate to low potential for physical and psychological dependence.
Xywav's approval was based on positive efficacy and safety findings from a multinational, Phase 3, double-blind, placebo-controlled, randomized-withdrawal study of 201 patients with narcolepsy and cataplexy. Of those patients, 134 were randomized 1:1 to receive the study drug or placebo. The data showed highly significant differences (P < .0001) in the weekly number of cataplexy attacks and in Epworth Sleepiness Scale scores between patients receiving Xywav and those receiving placebo.
"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," said Richard K. Bogan, MD, 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.
New indications
Qutenza indication now includes pain associated with foot DPN
Averitas's Qutenza (capsaicin 8% patch) has received an expanded indication for the treatment of adults with neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet, a progressive and debilitating complication of diabetes.
"Painful diabetic peripheral neuropathy has a significant impact on the day-to-day lives of millions of individuals, and we believe Qutenza can be a much-needed nonopioid treatment option for these patients," said Jan Adams, chief scientific officer, Grünenthal, of which Averitas is a subsidiary.
The patch was originally approved in the US in 2009 for the management of neuropathic pain associated with postherpetic neuralgia. It is the only topical, nonopioid pain treatment option for delivering prescription-strength capsaicin directly into the skin, subduing pain for up to 3 months. The therapy is also approved in Europe.
Orphengesic okayed as opioid-free analgesic for musculoskeletal pain
Galt Pharmaceuticals' Orphengesic Forte (orphenadrine citrate, aspirin, and caffeine combination) has been approved as a nonopioid, noncontrolled option for the management of mild to moderate pain associated with acute musculoskeletal disorders.
"This is a big win in the fight against the US opioid epidemic and the FDA's swift early action confirms the seriousness of the issue," said Barry Patel, Galt's CEO and cofounder. "Orphengesic Forte is a proven, safer pain management alternative healthcare providers can consider before prescribing an opioid."
FDA had designated the company's supplemental abbreviated new drug application as a priority review, and the agency approved it more than 2 months ahead of the scheduled goal date.
The orphenadrine citrate, aspirin, and caffeine combination was approved as Norgesic and Norgesic Forte tablets in November 2001 and discontinued in 2015.
Tags: FDA, US