Verona Pharma said that it plans to initiate the second phase of a two-part Phase 2 trial of its RPL554 ensifentrine DPI in COPD patients after the first part of the study demonstrated that the DPI produced significant improvement in FEV1. The company announced initiation of the study in December 2018. The Phase 2 study enrolled 37 moderate-to-severe COPD patients … [Read more...] about Verona announces positive interim data from Phase 2 study ensifentrine DPI
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Acorda launches Inbrija levodopa DPI in the US
Acorda Therapeutics has announced the US launch of the Inbrija levodopa dry powder inhaler in the US. In December 2018, he FDA approved Inbrija for the treatment of OFF episodes in Parkinson's disease patients taking carbidopa/levodopa. The DPI will be available to patients by prescription through certain specialty pharmacies. Acorda President and CEO Ron Cohen … [Read more...] about Acorda launches Inbrija levodopa DPI in the US
Oyster Point raises $93 million for Phase 3 development of intranasal dry eye therapies
Oyster Point Pharma said that it has raised $93 million in a Series B financing round and will use the proceeds for continued development of its OC-01 and OC-02 nicotine acetylcholine receptor (nAChR) agonist nasal sprays for the treatment of dry eye disease. In October 2018, Oyster Point announced that Phase 2b studies of each of the two nasal sprays had met … [Read more...] about Oyster Point raises $93 million for Phase 3 development of intranasal dry eye therapies
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