Milestone Pharmaceuticals has announced today that its MSP-2017 intranasal calcium channel antagonist has been assigned the unique non-proprietary name "etripamil" by the United States Adopted Name (USAN) Council. The company is developing the etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone CEO Philippe Douville … [Read more...] about Milestone’s intranasal calcium channel antagonist gets generic name “etripamil”
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Neurelis announces initiation of pivotal trials for intranasal diazepam
Neurelis says that it has received guidance from the FDA regarding clinical trial requirements for the company's NRL-1 intranasal diazepam for the treatment of acute repetitive seizures in epilepsy patients and is now initiating the pivotal trial program for the product. Neurelis President and CEO Craig C. Chambliss commented, "We were pleased to obtain guidance … [Read more...] about Neurelis announces initiation of pivotal trials for intranasal diazepam
Turing says that it is initiating Phase 1 clinical trials for intranasal ketamine
Turing Pharmaceuticals said that it has received a no objection letter from Health Canada regarding the initiation of Phase 1 trials of TUR-002 intranasal ketamine for the reduction of suicidal ideations and that it expects to complete the trials by mid-2016. The timing is in line with a November 2015 announcement from Turing that was made prior to the arrest and … [Read more...] about Turing says that it is initiating Phase 1 clinical trials for intranasal ketamine
Vectura reveals its US partner for generic fluticasone/salmeterol DPI: BI subsidiary Roxane Laboratories
Vectura Group has confirmed that its US partner for the VR315 fluticasone/salmeterol DPI and the VR506 generic fluticasone propionate DPI is Boehringer Ingelheim subsidiary Roxane Laboratories. The company is partnered with Sandoz on VR315 in the rest of the world. When Vectura announced the VR315 US licensing deal in August 2011, it referred to its partner as "a … [Read more...] about Vectura reveals its US partner for generic fluticasone/salmeterol DPI: BI subsidiary Roxane Laboratories
Cipla launches mobile app for management of asthma in India
Cipla has announced the launch of a mobile app called “My Breathefree,” which is intended to serve as a "virtual caregiver" for asthma patients in India. The app includes video demonstrations of correct use for various types of inhalers in 10 languages, as well as dose reminders, tracking tools for peak expiratory flow rate, a "trigger map," and other resources from … [Read more...] about Cipla launches mobile app for management of asthma in India
Discovery Labs initiates Phase 2b trial of Aerosurf
Discovery Laboratories has announced the initiation of a Phase 2b trial of Aerosurf aerosolized KL4 surfactant to treat respiratory distress syndrome (RDS) in premature infants. The trial, which is expected to enroll up to 250 patients will compare outcomes for infants receiving Aerosurf plus non-invasive nasal continuous positive airway pressure (nCPAP) to outcomes … [Read more...] about Discovery Labs initiates Phase 2b trial of Aerosurf
Alexza announces interim results from Phase 2a study of AZ-002
Alexza Pharmaceuticals has announced interim results from a Phase 2a study of AZ-002 inhaled alprazolam in epilepsy patients. Dose-related decreases in mean standardized photosensivity range (SPR), the study's primary endpoint, were noted 2 minutes post inhalation for 2 of the 3 doses tested, the company said. According to Alexza, AZ-002 was also well tolerated with … [Read more...] about Alexza announces interim results from Phase 2a study of AZ-002
Study finds intranasal glucagon effective for treatment of insulin-induced hypoglycemia
A study published online in the journal Diabetes Care on December 17, 2015 demonstrated non-inferiority of intranasal glucagon to intramuscular glucagon for the treatment of insulin-induced hypoglycemia in type 1 diabetes patients. The study found that intranasal glucagon successfully raised plasma glucose to the target level within 30 minutes after dosing in 98.7% of … [Read more...] about Study finds intranasal glucagon effective for treatment of insulin-induced hypoglycemia
Phase 1 clinical trial of Acorda’s inhaled zolmitriptan gets underway
Enrollment has begun for a Phase 1 clinical study of Acorda Therapeutics' CVT-427 zolmitriptan DPI for the treatment of migraines, the company said. The single ascending dose study, which is expected to enroll 32 healthy adults, will assess the safety and tolerability of four doses of CVT-427 and will compare the pharmacokinetics of the inhaled drug to the … [Read more...] about Phase 1 clinical trial of Acorda’s inhaled zolmitriptan gets underway
Sumatriptan nasal spray shortage expected to last until February 2016
According to the FDA, GlaxoSmithKline has reported that 20 mg and 5 mg dosages of its Imitrex nasal spray for the treatment of migraine headaches will be unavailable until February 2016 due to an API shortage. The shortage, which was reported to the FDA on November 20, 2015, affects both dosages of an authorized generic sumatriptan nasal spray distributed by Sandoz … [Read more...] about Sumatriptan nasal spray shortage expected to last until February 2016