US-based Onspira Therapeutics has announced that its OSP-101, an inhaled interleukin-1 receptor antagonist (IL-1Ra) for the treatment of bronchiolitis obliterans, has been granted orphan drug designation by the FDA. Onspira is a private company created by NeXeption in 2017, and OSP-101 is currently its only candidate. Onspira Therapeutics President and CEO Brian … [Read more...] about Onspira’s inhaled therapy for bronchiolitis obliterans gets orphan drug designation
Regulatory
UCB’s midazolam nasal spray NDA accepted by the FDA
UCB announced that the FDA has accepted its new drug application for USL261 midazolam nasal spray for the rescue treatment of seizures in epilepsy patients. The company announced in April 2018 that it had acquired rights to the nasal spray from former Upsher Smith subsidiary Proximagen. USL261 has previously received both orphan drug designation and fast track … [Read more...] about UCB’s midazolam nasal spray NDA accepted by the FDA
FDA advisory committee votes in favor of ALIS inhalation solution for patients with limited or no other treatment options
The FDA's Antimicrobial Drugs Advisory Committee (AMDAC) voted against the efficacy and safety of Insmed's ALIS amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) for all patients but voted in favor of its efficacy and safety for patients with limited or no other … [Read more...] about FDA advisory committee votes in favor of ALIS inhalation solution for patients with limited or no other treatment options
FDA accepts NDA for Ryaltris, sets PDUFA date
The FDA has accepted Glenmark Pharmaceuticals' NDA for Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis, with the PDUFA date for completion of the review set for March 21, 2019, the company said. Glenmark announced submission of the NDA in May 2018. Positive results from Phase 3 studies of Ryaltris … [Read more...] about FDA accepts NDA for Ryaltris, sets PDUFA date
Eli Lilly submits NDA, MAA for intranasal glucagon
During its second quarter earnings call on July 24, 2018, Eli Lilly announced that it had filed regulatory submissions with the FDA and with the EMA for its intranasal glucagon for the treatment of severe hypoglycemia in diabetes patients taking insulin. Lilly acquired worldwide rights to the nasal glucagon powder from Locemia in 2015. The MAA was submitted under … [Read more...] about Eli Lilly submits NDA, MAA for intranasal glucagon
Clinical development program for Penthrox put on hold
After meeting with the FDA regarding the clinical program for US approval of its Penthrox methoxyflurane inhaler, Medical Developments International (MVP) said that it expects to receive a clinical hold letter from the agency within the next two months. Penthrox is currently approved for the treatment of pain in numerous countries, including Canada, and much of … [Read more...] about Clinical development program for Penthrox put on hold
FDA reopens comment period for draft guidance on MDI and DPI quality considerations
The FDA has issued a notice that it has reopened the comment period for the “Metered Dose Inhaler and Dry Powder Inhaler Drug Products—Quality Considerations; Draft Guidance for Industry,” which was published in April, 2018. The FDA originally gave interested parties until June 18, 2018 to submit input; the comment period has now been extended until September 18, … [Read more...] about FDA reopens comment period for draft guidance on MDI and DPI quality considerations
3M DDS highlights addition of dose indicator on Proventil inhaler
3M Drug Delivery Systems has announced that its Proventil HFA albuterol MDI, which is marketed and distributed by Merck, now includes a top-mounted dose indicator. The FDA approved an sNDA for Proventil HFA with the dose indicator in September 2017, and Merck launched the new version of Proventil HFA in March 2018, according to 3M DDS. 3M Inhalation Drug … [Read more...] about 3M DDS highlights addition of dose indicator on Proventil inhaler
FDA clears IND for Oyster Point’s OC-01 nasal spray for dry eye disease
Oyster Point Pharma has announced that its investigational new drug application for OC-01, a nicotine acetylcholine receptor (nAChR) agonist nasal spray, has been cleared by the FDA. OC-01 and another nAChR nasal spray, OC-02, are both in Phase 2 development for the treatment of dry eye disease. The company said that an IND for OC-02 was cleared in October 2017, … [Read more...] about FDA clears IND for Oyster Point’s OC-01 nasal spray for dry eye disease
Impel plans for Phase 3 study of intranasal DHE for migraine
According to Impel NeuroPharma, the FDA has given the company a notice to proceed with clinical study of INP101 intranasal dihydroergotamine (DHE) for the treatment of acute migraine. A Phase 3 study is expected to begin enrolling patients in the second half of this year. The company said that it had recently submitted an investigational new drug application to the … [Read more...] about Impel plans for Phase 3 study of intranasal DHE for migraine