Three weeks after recalling numerous lots of desmopressin nasal sprays in the UK and a number of other countries, Ferring has issued a recall of all lots of DDAVP 10 mcg/0.1ml, Stimate 1.5 mg/ml, and generic desmopressin 10 mcg/0.1ml nasal sprays in the US "due to superpotency or amounts of desmopressin higher than specified." The recall includes 6 lots of DDAVP, 15 … [Read more...] about Desmopressin nasal sprays recalled in US
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Phase 3 trial of Levo’s intranasal carbetocin for PWS misses primary endpoint
A Phase 3 trial of Levo Therapeutics' LV-101 intranasal carbetocin in children with Prader-Willi Syndrome (PWS) failed to meet its primary endpoint, the company said. Enrollment in the study, which began in 2018, was stopped earlier than anticipated due to the COVID-19 pandemic, winding up with 119 patients in the primary analysis set. The CARE-PWS trial compared … [Read more...] about Phase 3 trial of Levo’s intranasal carbetocin for PWS misses primary endpoint
NeuroRx gets clearance for clinical trial of inhaled aviptadil for COVID-19
The FDA has cleared an IND for NeuroRx to conduct a clinical trial of an inhaled formulation of its RLF-100 aviptadil in patients with moderate or severe COVID-19, the company said. NeuroRx recently announced that an intravenous formulation of RLF-100 has shown promising results in patients with severe COVID-19 and that researchers in Brazil have demonstrated that … [Read more...] about NeuroRx gets clearance for clinical trial of inhaled aviptadil for COVID-19
Bryn Pharma raises $11 million for continued development of its epinephrine nasal spray
Bryn Pharma said that it has raised $11 million in an extension of the financing that raised over $17 million in October 2019 to fund activities related to its BRYN-NDS1C epinephrine nasal spray candidate, which is delivered via Aptar Pharma's Bidose nasal device. According to Bryn, proceeds from this financing will be used for continued development of BRYN-NDS1C, as … [Read more...] about Bryn Pharma raises $11 million for continued development of its epinephrine nasal spray
Atossa gets approval for Phase 1 study of AT-301 nasal spray
Atossa Therapeutics said that it has gotten the go-ahead for a Phase 1 clinical study of its AT-301 nasal spray, which the company is developing for the treatment of COVID-19, and expects to begin enrollment within a month. Atossa previously announced that it had contracted with Summit Biosciences for development and manufacturing of the nasal spray and with Advance … [Read more...] about Atossa gets approval for Phase 1 study of AT-301 nasal spray
FDA approves Spravato esketamine nasal spray for depression with suicidal ideation
The FDA has approved Janssen Pharmaceutical's sNDA for the expanded use of Spravato esketamine CIII nasal spray for the treatment of major depressive disorder with acute suicidal ideation or behavior, the company said. Spravato was initially approved by the FDA in March 2019 for the treatment of treatment-resistant depression, and Janssen announced the … [Read more...] about FDA approves Spravato esketamine nasal spray for depression with suicidal ideation
TFF says dosing complete in Phase 1 trial of its dry powder voriconazole
TFF Pharmaceuticals said that the final subject has been dosed in a Phase 1 SAD/MAD study of its voriconazole inhalation powder, which the company is developing for the treatment of invasive pulmonary aspergillosis (IPA). The SAD/MAD study was initiated in November 2019, and the company recently announced topline safety results from the trial. TFF President and … [Read more...] about TFF says dosing complete in Phase 1 trial of its dry powder voriconazole
FDA approves Breztri Aerosphere for the treatment of COPD
AstraZeneca has announced that its Breztri Aerosphere (PT010) budesonide / glycopyrrolate / formoterol fumarate MDI has been approved by the FDA for the treatment of COPD. The FDA had previously issued a complete response letter to AstraZeneca’s NDA for PT010 in the fall of 2019. In August 2019, the company announced that the Phase 3 ETHOS trial of Breztri had … [Read more...] about FDA approves Breztri Aerosphere for the treatment of COPD
CHMP recommends approval of Arikayce inhaled liposomal amikacin for NTM lung infections
According to Insmed, the EMA's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding approval of the company's Arikayce nebulized liposomal amikacin for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in patients who do not have cystic fibrosis. According to … [Read more...] about CHMP recommends approval of Arikayce inhaled liposomal amikacin for NTM lung infections
Milestone Pharmaceuticals raises $25 million, provides update on etripamil development
Milestone Pharmaceuticals said that it has raised $25 million from RTW Investments in a private placement and indicated that the proceeds would be sufficient for company operations through the second quarter of 2022. The company also announced that it had reached an agreement with the FDA regarding modifications to the design of a pivotal trial of its etripamil nasal … [Read more...] about Milestone Pharmaceuticals raises $25 million, provides update on etripamil development