Business
Aytu BioPharma Receives Orphan Drug Designation from FDA for AR101 for Treatment of Vascular Ehlers-Danlos Syndrome
ENGLEWOOD, CO / ACCESSWIRE / December 8, 2021 / Aytu BioPharma, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel
About this update from Aytu Biopharma, Inc.
[{"type":"text","content":"ENGLEWOOD, CO / ACCESSWIRE / December 8, 2021 / Aytu BioPharma, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to AR101 (enzastaurin) for the treatment of Ehlers-Danlos Syndrome. Treatment of vascular Ehlers-Danlos Syndrome (VEDS) is within the scope of this orphan drug designation. The company plans to launch a single pivotal trial, the PREVEnt Trial, of AR101 in patients with VEDS in the first half of 2022. VEDS is a rare genetic disorder typically diagnosed in childhood and characterized by arterial aneurysm, dissection and rupture, bowel rupture and rupture of the gravid uterus.\"Receiving Orphan Drug designation for AR101 underscores the unmet need for patients with VEDS, for which there are currently no FDA-approved treatments,\" said Josh Disbrow, Chief Executive Officer of Aytu BioPharma. \"This designation is an important milestone, and we look forward to working with the FDA as we advance this potential treatment option with the goal of positively impacting patients diagnosed with this devastating disease.\"The FDA grants Orphan Drug designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug designation affords Aytu certain financial incentives to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval.About Aytu BioPharma, Inc.Aytu BioPharma is a specialty pharmaceutical company with a growing commercial portfolio of prescription therapeutics and consumer health products. The company's primary prescription products treat attention deficit hyperactivity disorder (ADHD) and other common pediatric conditions. Aytu markets ADHD products Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) and Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING). The company also markets ZolpiMist®, a short-term treatment for insomnia characterized by difficul...