Regulatory

The FDA has approved Pfizer's Zavzpret zavegepant (BHV-3500) calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the treatment of migraine. Pfizer said that it expects to launch Zavzpret in July 2023. The FDA accepted the NDA for the zavegepant (formerly "vazegepant") nasal spray submitted by Biohaven Pharmaceuticals in May 2022. Biohaven … [Read more...] about FDA approves Zavzpret zavegepant nasal spray for the treatment of migraine

The FDA has approved Amphastar Pharmaceuticals' NDA for 4 mg intranasal naloxone for the treatment of opioid overdose. According to the company, the nasal spray is delivered via a proprietary delivery device. A previous Amphastar NDA for a 2mg naloxone nasal spray received a CRL from the NDA in 2017, with the FDA asking for additional human factors and device … [Read more...] about FDA approves Amphastar’s naloxone nasal spray for the treatment of opioid overdose

According to Amneal Pharmaceuticals, the FDA has accepted the company's ANDA for a generic version of Narcan naloxone nasal spray, 4 mg, for the treatment of opioid overdose. Amneal generics Chief Commercial Officer Andy Boyer said, "Naloxone hydrochloride nasal spray is a critical tool in addressing the opioid public health emergency across the United States. We … [Read more...] about FDA accepts Amneal’s ANDA for generic of Narcan naloxone nasal spray

Optinose announced that it has submitted an sNDA for a label expansion of Xhance fluticasone propionate nasal spray (OPN-375) for the treatment of chronic sinusitis without nasal polyps. Xhance has been approved for the treatment of nasal polyps in the US since 2017. In June 2022, the company announced that the second of two Phase 3 trials of Xhance for the treatment … [Read more...] about Optinose submits sNDA for Xhance fluticasone propionate nasal spray to treat chronic sinusitus

The FDA's Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee have voted unanimously in favor of over-the-counter use of Narcan naloxone nasal spray for the reversal of opioid overdose.  In December 2022, the FDA accepted Emergent BioSolutions' sNDA for OTC sales of Narcan for priority review, with a PDUFA goal … [Read more...] about FDA advisory committee recommends approval of Narcan naloxone nasal spray for OTC sales

Orexo announced that it has submitted an NDA for its OX124 intranasal naloxone for the reversal of opioid overdose. The company notes that FDA review is likely to take a little more than a year and says that it is planning for a launch in the first half of 2024. OX124 is based on the company's amorphOX particle engineering technology, which also underlies its … [Read more...] about Orexo submits NDA for OX124 intranasal naloxone

According to Opiant Pharmaceuticals, the FDA has accepted the company's NDA for OPNT003 intranasal nalmefene for the treatment of opioid overdose for priority review and has set a PDUFA date of May 22, 2023. In October 2022, Opiant announced that it had completed its rolling submission of the NDA for OPNT003. The company has received funding from the … [Read more...] about FDA accepts Opiant’s NDA for OPNT003 intranasal nalmefene