Oyster Point Pharma has announced that the Phase 2b PEARL study of its OC-02 intranasal nicotinic acetylcholine receptor (nAChR) agonist for the treatment of dry eye disease demonstrated a statistically significant increase in production of tear film as well as a statistically significant reduction in symptoms for patients using OC-02 compared to placebo. The … [Read more...] about Phase 2b study of Oyster Point’s nasal spray for dry eye disease meets primary endpoints
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Pulmatrix announces results from Phase 1/1b trial of its Pulmazole itraconazole DPI
According to Pulmatrix, a recent Phase 1/1b study of its Pulmazole (PUR1900) itraconazole DPI for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients with asthma showed that total systemic exposure in healthy volunteers was significantly lower than historical levels for oral itraconazole and that the drug was well tolerated at all doses … [Read more...] about Pulmatrix announces results from Phase 1/1b trial of its Pulmazole itraconazole DPI
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
Levo Therapeutics to restart development of intranasal carbetocin for Prader-Willi syndrome
Levo Therapeutics has announced that it plans to initiate a Phase 3 trial of LV-101 intranasal carbetocin for the treatment of Prader-Willi syndrome (PWS) before the end of 2018. The company said that it acquired rights to the formulation from Ferring Pharmaceuticals in August 2017 and is now publishing results from a Phase 2 study sponsored by Ferring that concluded … [Read more...] about Levo Therapeutics to restart development of intranasal carbetocin for Prader-Willi syndrome
Arch Biopartners puts Phase 1 trial of AB569 on hold, will request pre-IND meeting with FDA
Canadian biotech Arch Biopartners has announced that it will put an ongoing Phase 1 safety study of its AB569 ethylenediaminetetraacetic acid (EDTA)/sodium nitrite bactericidal inhalation solution on hold and will ask the FDA for a pre-IND meeting for AB569. The study began recruiting volunteers in February 2018. Arch Biopartners CEO Richard Muruve said, “We have … [Read more...] about Arch Biopartners puts Phase 1 trial of AB569 on hold, will request pre-IND meeting with FDA
Insys says PK study shows intranasal epinephrine bioavailability similar to intramuscular formulations
Insys Therapeutics said that preliminary data from a Phase 1 pharmacokinetics study comparing its intranasal epinephrine formulation to EpiPen intramuscular epinephrine in 60 subjects with seasonal allergies showed similar bioavailability and rapid drug absorption for the nasal spray. The company did not provide any details. Insys announced initiation of the study … [Read more...] about Insys says PK study shows intranasal epinephrine bioavailability similar to intramuscular formulations
Pulmatrix publishes data from Phase 1 study of its PUR0200 tiotropium DPI
Data from a Phase 1 study of Pulmatrix's PUR0200 lactose-free dry powder formulation of tiotropium has been published online in the British Journal of Clinical Pharmacology. The dose-ranging study in patients with moderate-to-severe COPD compared 3 doses of PUR0200 (3 μg, 6 μg, or 9 μg) to Spriva Handihaler (18 μg) and placebo. All doses of PUR0200 produced a … [Read more...] about Pulmatrix publishes data from Phase 1 study of its PUR0200 tiotropium DPI
Spyryx announces encouraging data from ongoing Phase 2 study of SPX-101 for CF
Spyryx Biosciences has announced that data from the first cohort of the Phase 2 HOPE-1 (Hydration for Optimal Pulmonary Effectiveness) study, which was initiated in October 2017, demonstrate improvement in lung function for cystic fibrosis patients independent of type of CF mutation after treatment with SPX-101, an inhaled SPLUNC1-derived peptide. The 46 patients … [Read more...] about Spyryx announces encouraging data from ongoing Phase 2 study of SPX-101 for CF
Impel NeuroPharma initiates Phase 2a study of INP103 intranasal levodopa for Parkinson’s disease
Impel NeuroPharma has announced the initiation of the Phase 2a THOR 201 study of INP103 intranasal levodopa compared to placebo for the treatment of OFF episodes in Parkinson's disease patients. INP103 is delivered by Impel's Precision Olfactory Delivery (POD) device. The safety and PK/PD study is expected to enroll 24 patients who will receive one of 3 doses of … [Read more...] about Impel NeuroPharma initiates Phase 2a study of INP103 intranasal levodopa for Parkinson’s disease
Apotex recalls lot of fluticasone nasal spray in US
Apotex has issued a voluntarily recall for one lot of fluticasone propionate nasal spray (lot NJ4501), which was shipped to wholesalers and distributors throughout the US and has an expiration date of July 2020. Apotex said that the FDA is aware of the recall and wholesalers and distributors have been notified. According to the company, a consumer complaint … [Read more...] about Apotex recalls lot of fluticasone nasal spray in US