ARS Pharmaceuticals announced that a Phase 2 trial of Neffy epinephrine nasal spray in patients with chronic spontaneous demonstrated that 1 mg and 2 mg doses of the intranasal epinephrine both produced statistically significant and clinically meaningful improvement in symptoms such as hives and itchy skin as soon as 5 minutes post dose. The inpatient study of Neffy, … [Read more...] about ARS Pharmaceuticals says Phase 2 trial of Neffy epinephrine nasal spray for urticaria met primary endpoints
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Milestone says it will resubmit its NDA for etripamil nasal spray
Milestone Pharmaceuticals says that it held a Type A meeting with the FDA following receipt of a Refuse to File letter in December 2023 in response to the company's NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). According to Milestone, the agency did not request any additional clinical trials. The company says that … [Read more...] about Milestone says it will resubmit its NDA for etripamil nasal spray
ReCode Therapeutics initiates Phase 1 trial of RCT2100 inhaled mRNA therapy for CF
ReCode Therapeutics has announced the initiation of a Phase 1 safety and tolerability study of RCT2100 inhaled CFTR mRNA-based therapy, which the company is developing for cystic fibrosis patients who do not benefit from CFTR modulators. The study is expected to enroll 32 healthy adults and will evaluate a single dose of nebulized RCT2100 against placebo. According … [Read more...] about ReCode Therapeutics initiates Phase 1 trial of RCT2100 inhaled mRNA therapy for CF
The DDL New Researcher Network Expands its Activities
By Julia Berends, Cord Kühnl, and Lucy Goodacre The New Researcher Network (NRN) was founded as a sub-committee of the Drug Delivery to the Lungs (DDL) conference in 2019 to actively foster interaction and collaboration among early-career OINDP researchers and to build a robust community of emerging scholars. The first NRN lunch and evening session took place at … [Read more...] about The DDL New Researcher Network Expands its Activities
United Therapeutics sues the FDA alleging improper handling of Liquidia’s sNDA for Yutrepia treprostinil DPI
In addition to ongoing litigation against Liquidia Corporation alleging infringement of patents covering Tyvaso inhaled treprostinil by Liquidia's Yutrepia treprostinil DPI, United Therapeutics Corporation announced that it is now suing the FDA over its handling of Liquidia's sNDA to add PH-ILD as an indication for Yutrepia. United Therapeutics calls the sNDA … [Read more...] about United Therapeutics sues the FDA alleging improper handling of Liquidia’s sNDA for Yutrepia treprostinil DPI
ARS Pharma announces results of Neffy intranasal epinephrine study, plans to file response to CRL
ARS Pharmaceuticals said that it intends to file a response to the September 2023 complete response letter to its NDA for Neffy epinephrine nasal spray “early in the second quarter of 2024,” with the response supported by data from a repeat dose study with nasal allergen challenge as requested by the FDA. According to ARS, topline results from the study, which … [Read more...] about ARS Pharma announces results of Neffy intranasal epinephrine study, plans to file response to CRL
LTR Pharma initiates BE study of Spontan vardenafil nasal spray
LTR Pharma has announced the initiation of a bioequivalence study of its Spontan vardenafil nasal spray, which the company is developing for the treatment of erectile dysfunction. According to LTR, the study will compare a single dose of Spontan, 5 mg (2 sprays of 2.5 mg each) to 10 mg tablets of vardenafil in healthy adult males. The company says that it intends to … [Read more...] about LTR Pharma initiates BE study of Spontan vardenafil nasal spray
Apotex recalls two lots of APO-Mometasone nasal spray
Health Canada has announced that Apotex is recalling 2 lots of its mometasone nasal spray, a generic of Nasonex, due to possible contamination with Burkholderia cepacia complex. Lot TX5343 has an expiration date of September 2025, and lot TZ2586 has an expiration date in October 2025. APO-Mometasone nasal spray is approved in Canada for the treatment of allergies … [Read more...] about Apotex recalls two lots of APO-Mometasone nasal spray
Q&A with Copley’s Clair Brooks on in vitro testing for LGWP MDI reformulation
Copley Application Specialist Clair Brooks discusses new EMA guidance on data requirements associated with the transition to low global warming potential (LGWP) propellants in metered dose inhalers and strategies for the successful application of in vitro testing within this context. How does the 2023 EMA Q&A clarify data requirements for the LGWP transition … [Read more...] about Q&A with Copley’s Clair Brooks on in vitro testing for LGWP MDI reformulation
SaNOtize initiates Phase 2 trial of its nitric oxide nasal spray in patients with sinusitis
SaNOtize has initiated a Phase 2 study of its nitric oxide nasal spray (NONS) for the treatment of recurrent acute rhinosinusitis, the company said. The trial is expected to enroll 186 patients who will receive either the NO nasal spray or placebo at the beginning of an episode of sinusitis, with time to symptom resolution as a primary endpoint. Previous trials of … [Read more...] about SaNOtize initiates Phase 2 trial of its nitric oxide nasal spray in patients with sinusitis