According to Oyster Point Pharma, the Phase 2 MYSTIC study of its OC-01 varenicline nasal spray for the treatment of dry eye disease met its primary endpoint, demonstrating significant improvement in tear production at Day 84 compared to control as measured by Schirmer's score. Both doses tested met that endpoint, with a 1.2 mg/ml dose achieving an 11.0 mm mean change … [Read more...] about Phase 2 study of Oyster Point’s OC-01 nasal spray for dry eye disease meets primary endpoint
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AI Therapeutics provides update on inhaled rapamycin
AI Therapeutics (formerly LAM Therapeutics) said that it is seeking a partner to advance its LAM-001 inhaled rapamycin into Phase 3 trials for the treatment of lymphangioleiomyomatosis (LAM disease) and into Phase 2 for the treatment of pulmonary arterial hypertension (PAH). The company said that LAM-001 has been granted Orphan Drug designation for LAM in Europe and … [Read more...] about AI Therapeutics provides update on inhaled rapamycin
Positive topline results for Phase 2/3 trial of Biohaven’s intranasal vazegepant for migraine
Biohaven Pharmaceutical has announced that a Phase 2/3 trial of its intranasal vazegepant (BHV-3500) demonstrated that 10 and 20 mg doses of the intranasal migraine therapy were more effective than placebo for pain relief and that the drug was well tolerated with no indication of liver toxicity. Biohaven announced the initiation of the study in April 2019. The … [Read more...] about Positive topline results for Phase 2/3 trial of Biohaven’s intranasal vazegepant for migraine
Phase 2 trial of Theravance’s TD-8236 inhaled JAK inhibitor gets underway
Theravance Biopharma announced that the first patient has been dosed in a Phase 2 study of its TD-8236 inhaled dry powder pan-JAK inhibitor which the company is developing for the treatment of inflammatory lung diseases. In September 2019, the company announced positive results from a Phase 1 SAD/MAD study of TD-8236. The Phase 2 allergen challenge study will … [Read more...] about Phase 2 trial of Theravance’s TD-8236 inhaled JAK inhibitor gets underway
Otitopic announces results from Phase 1 trial of its inhaled aspirin
Otitopic has announced that a Phase 1 trial of its Asprihale dry powder aspirin found that the inhaled formulation demonstrated antithrombotic effects at 2 minutes post dose compared to 30 minutes post dose for a 162 mg chewable aspirin tablet. Both the inhaled and chewable aspirin maintained maximum antithrombotic effects at 24 hours post dose. In February 2019, … [Read more...] about Otitopic announces results from Phase 1 trial of its inhaled aspirin
TFF initiates Phase 1 trial of inhaled voriconazole
TFF Pharmaceuticals has announced the initiation of Phase 1 trial of its dry powder voriconazole, which the company is developing for the treatment of invasive pulmonary aspergillosis (IPA). The Phase I SAD/MAD study will be conducted in Canada and will enroll a total of 64 healthy subjects, 32 in each part. The company recently raised $22 million in an initial … [Read more...] about TFF initiates Phase 1 trial of inhaled voriconazole
Insmed appoints Martina Flammer as Chief Medical Officer, provides update on Arikayce
Insmed has announced the appointment of Martina Flammer as Chief Medical Officer, effective mid-December 2019. Flammer was most recently Senior VP Customer Value at Boehringer Ingelheim and her previous positions include VP Medicine, Regulatory Affairs & Pharmacovigilance at BI Canada; VP Clinical Development & Medical Affairs of BI's Specialty Care Business … [Read more...] about Insmed appoints Martina Flammer as Chief Medical Officer, provides update on Arikayce
Studies show Penthrox is superior to standard of care for acute trauma pain
Medical Developments International (MDI) has announced data from multiple European studies demonstrating the benefits of MDI's Penthrox methoxyflurane inhaler for the treatment of pain from acute trauma. Among the findings announced, Penthrox was shown to be superior to intravenous morphine, NSAIDS, paracetamol (acetaminophen), and ketoprofen in trauma settings; … [Read more...] about Studies show Penthrox is superior to standard of care for acute trauma pain
Boehringer Ingelheim initiates Phase 2 trial of inhaled ENaC inhibitor for CF
Boehringer Ingelheim has announced the initiation of a Phase 2 clinical trial of its BI 1265162 inhaled epithelial sodium channel (ENaC) inhibitor delivered via the Respimat SMI plus standard of care in cystic fibrosis patients. The study is expected to enroll 98 patients aged 12 and over and will compare twice daily doses of BI 1265162 inhalation solution to … [Read more...] about Boehringer Ingelheim initiates Phase 2 trial of inhaled ENaC inhibitor for CF
Milestone Pharmaceuticals initiates Phase 3 safety study of intranasal etripamil for PVST
Milestone Pharmaceuticals has announced the initiation of the Phase 3 NODE-303 open-label safety study of the company's intranasal etripamil for the treatment of paroxysmal supraventricular tachycardia (PSVT). NODE-303 is the third of three trials in the Phase 3 program for etripamil. NODE-301 was initiated in August 2018, and NODE-302 got underway in December 2018. … [Read more...] about Milestone Pharmaceuticals initiates Phase 3 safety study of intranasal etripamil for PVST