Bryn Pharma has presented data from a bioavailability study of its Utuly epinephrine nasal spray demonstrating that 13.2 mg dose of Utuly absorbed as fast and produced higher and longer-lasting epinephrine plasma levels than a 0.3 mg autoinjector. Compared to a 0.5 mg dose of epinephrine delivered via manual syringe, Utuly absorbed faster and reached comparable or … [Read more...] about Bryn Pharma says study demonstrated that its Utuly intranasal epinephrine “provides an enhanced PK profile” compared to autoinjector
News
Aerami expands development of AER-901 inhaled imatinib to include PH-ILD
Aerami Therapeutics announced that it will develop its AER-901 nebulized imatinib for pulmonary hypertension associated with interstitial lung disease (PH-ILD) in addition to pulmonary arterial hypertension (PAH). The FDA granted orphan drug designation to AER-901 for the PAH indication in August 2021, and the company says that it recently completed a Phase 1 trial of … [Read more...] about Aerami expands development of AER-901 inhaled imatinib to include PH-ILD
ARS Pharmaceuticals reacquires European rights to ARS-1 intranasal epinephrine from Recordati
According to ARS Pharmaceuticals, Recordati has returned the European marketing rights to ARS-1 epinephrine nasal spray (Neffy) in return for an unspecified amount up front plus future milestone payments connected to European approval and launch and royalties on sales in the EU, UK and other countries covered by the original deal. In September 2020, Recordati … [Read more...] about ARS Pharmaceuticals reacquires European rights to ARS-1 intranasal epinephrine from Recordati
Impel announces “streamlining plan,” halts development of INP105 intranasal olanzapine
Impel Pharmaceuticals announced that it will cut 16% of its workforce and halt development of INP105 intranasal olanzapine for the treatment of agitation in autism spectrum disorder. The company also said that its Chief Medical Officer, Stephen Shrewsbury, will be leaving Impel at the end of March. According to the company, the move will allow the company to … [Read more...] about Impel announces “streamlining plan,” halts development of INP105 intranasal olanzapine
BiomX announces data from Phase 1b trial of its BX004 inhaled phage cocktail for the treatment of lung infections in CF patients
Israeli biotech BiomX has announced data from the first part of a Phase 1b/2a trial of the company's BX004 nebulized phage cocktail for the treatment of P. aeruginosa lung infections in cystic fibrosis patients demonstrating a reduction in P. aeruginosa burden. The first portion of the study, which is supported by the Cystic Fibrosis Foundation, enrolled 9 CF patients … [Read more...] about BiomX announces data from Phase 1b trial of its BX004 inhaled phage cocktail for the treatment of lung infections in CF patients
Firebrick Pharma files Pediatric Investigation Plan for Nasodine povidone-iodine nasal spray
Firebrick Pharma announced that it has filed a Pediatric Investigation Plan (PIP) with the EMA's Pediatric committee for its Nasodine povidone-iodine nasal spray as the company plans to submit a marketing application for Nasodine by the end of 2023. In April 2022, Firebrick initiated a Phase 2 study of Nasodine for the treatment of COVID-19. A Phase 3 trial of … [Read more...] about Firebrick Pharma files Pediatric Investigation Plan for Nasodine povidone-iodine nasal spray
Optinose submits sNDA for Xhance fluticasone propionate nasal spray to treat chronic sinusitus
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
Beckley Psytech gets go-ahead for Phase 2b study of BPL-003 intranasal synthetic 5-MeO-DMT
Beckley Psytech said that the FDA has approved the company's IND for a Phase 2b study comparing 2 doses of BPL–003 intranasal dry powder synthetic 5-MeO-DMT (mebufotenin) in patients with treatment-resistant depression. According to Beckley Psytech, the proposed Phase 2b study, which is expected to be initiated in the first half of this year, is the first ever … [Read more...] about Beckley Psytech gets go-ahead for Phase 2b study of BPL-003 intranasal synthetic 5-MeO-DMT
AAHI gets $3 million for development of antiviral nasal spray
The non-profit Access to Advanced Health Institute (formerly the Infectious Disease Research Institute) said that it has received an award of up to $3 million for development of a prototype antiviral nasal spray from the US Department of Defense (D0D). The news comes soon after AAHI announced that it had received an award of worth up to $9.9 million for development of … [Read more...] about AAHI gets $3 million for development of antiviral nasal spray
Codagenix raises $25 million for development of CodaVax-RSV intranasal vaccine against RSV
Codagenix said that it has completed a $25 million Series B extension financing, with funds primarily going to support development of its CodaVax-RSV intranasal live attenuated vaccine against respiratory syncytial virus. The FDA recently granted Fast Track designation to CodaVax-RSV. Investors in this funding round included the Serum Institute of India, Euclidean … [Read more...] about Codagenix raises $25 million for development of CodaVax-RSV intranasal vaccine against RSV