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FDA issues new and revised product specific guidances for five nasal sprays

The FDA has issued a new product-specific guidance for dihydroergotamine mesylate nasal spray and revised guidances for fluticasone propionate; azelastine hydrochloride/fluticasone propionate; mometasone furoate; and triamcinolone acetonide nasal sprays since February 1, 2019. According to the agency, the latest batch of guidances issued includes a total of 74 … [Read more...] about FDA issues new and revised product specific guidances for five nasal sprays

Merxin and Perlen Packaging team up to develop cannabis inhalers

Merxin Ltd and Perlen Packaging have announced that they will co-develop inhaled cannabis products based on Perlen’s BLISTair single use dry powder inhaler, with Merxin developing the formulations and marketing the cannabis DPIs. The BLISTair device is completely manufactured on a blister machine, without any molded parts, creating an inhaler from thermoformed … [Read more...] about Merxin and Perlen Packaging team up to develop cannabis inhalers

Aradigm says FDA “continues to have concerns” regarding data from Phase 3 trials of Apulmiq

Aradigm Corporation, which recently announced that it has filed for bankruptcy, said that it held a Type B meeting with the FDA on January 25, 2019 at which the agency expressed continued concerns about data from the ORBIT-3 and ORBIT-4 trials of Apulmiq inhaled dual release ciprofloxacin for the treatment of P. aeruginosa lung infections in non-cystic fibrosis … [Read more...] about Aradigm says FDA “continues to have concerns” regarding data from Phase 3 trials of Apulmiq

Opiant stops development of OPNT001 naloxone nasal spray for the treatment of bulimia

Opiant Pharmaceuticals said that it has discontinued development of OPNT001 naloxone nasal spray for the treatment of bulimia nervosa (BN) after a Phase 2 study failed to meet its primary endpoint. The company had announced the initiation of the study in March 2017. Opiant CEO Roger Crystal commented, “Based on these results, Opiant will not allocate further … [Read more...] about Opiant stops development of OPNT001 naloxone nasal spray for the treatment of bulimia

RDD Europe 2019 to address Brexit and other hot topics

RDD Europe 2019 will take place May 7-10 at the Estoril Congress Center outside of Lisbon. Organizers expect approximately 500 inhaled and nasal drug specialists from industry, academia, and regulatory agencies to attend this year's meeting. Richard Dalby of RDD Online, which co-organizes the meeting with Aptar Pharma, notes that one of the current hot topics of … [Read more...] about RDD Europe 2019 to address Brexit and other hot topics

RDD Europe workshop topics: new propellant, devices, and tech

One of the distinguishing features of RDD Europe is the workshop session, when a dozen companies offer 60-minute presentations on their latest technology, products, or services to small groups of 10-40 people at a time. Each workshop is presented 3 times during the session, and RDD Europe attendees have the opportunity to select 3 of the 12 sessions. "The … [Read more...] about RDD Europe workshop topics: new propellant, devices, and tech

Satsuma announces Phase 1 results, plans for Phase 3 trial of its intranasal DHE for the treatment of migraine

Satsuma Pharmaceuticals, which was spun out from SNBL in 2017 specifically for the purpose of developing STS 101 intranasal dihydroergotamine (DHE) for the treatment of migraine, said that a Phase 1 clinical trial demonstrated that STS101 was well tolerated, with none of the typical side effects of injected DHE such as nausea and vomiting. STS101 was rapidly absorbed … [Read more...] about Satsuma announces Phase 1 results, plans for Phase 3 trial of its intranasal DHE for the treatment of migraine

ARS Pharmaceuticals’ intranasal epinephrine gets Fast Track designation

ARS Pharmaceuticals said that the FDA has granted Fast Track designation to its ARS-1 intranasal epinephrine, which is in development for the treatment of anaphylaxis. In December 2018, the company announced that it had raised $20 million for clinical development of ARS-1. ARS Pharmaceuticals President and CEO Richard Lowenthal commented, “The FDA’s decision to … [Read more...] about ARS Pharmaceuticals’ intranasal epinephrine gets Fast Track designation

Impel NeuroPharma appoints Jennifer L. Berman as VP of Marketing

Intranasal drug developer Impel NeuroPharma has announced the appointment of Jennifer L. Berman VP of Marketing.  Berman was most recently Worldwide Brand Director at Novartis Pharmaceuticals. In December 2018, Impel announced that it had raised $67.5 million in a Series D financing round for continued development of intranasal products based on its Precision … [Read more...] about Impel NeuroPharma appoints Jennifer L. Berman as VP of Marketing