Evoke Pharma has announced that a Phase 3 trial of EVK-001 intranasal metoclopramide in 205 female diabetic gastroparesis patients failed to achieve its primary endpoint, which was improvement of symptoms at Week 4. EVK-001 and placebo treatment both produced similar improvement at Week 4. Results from a Phase 2b study announced in January 2014 had shown superior … [Read more...] about Evoke’s Phase 3 trial of intranasal metoclopramide fails to meet primary endpoint
Medical
Positive Phase 1 results for Pulmatrix’s PUR0200 DPI
Pulmatrix has announced topline results from the Phase 1 bioavailability trial of Pulmatrix's PUR0200 generic tiotropium DPI initiated in January 2016 and completed in May 2016. The company had previously announced positive Phase 1b results for a trial of PUR0200 in COPD patients. The 7-way crossover study involved 42 healthy subjects who each received a dose of … [Read more...] about Positive Phase 1 results for Pulmatrix’s PUR0200 DPI
Phase 3 study shows GSK’s FF/UMEC/VI combination improves lung function and quality of life better than Symbicort
GlaxoSmithKline and Innoviva have presented data from the FULFIL study of its fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI versus Symbicort for COPD, reiterating that the data support the company's plans to file an NDA for the product by the end of the year as recently announced as well as filing for approval in the EU by the end of 2016. The study met … [Read more...] about Phase 3 study shows GSK’s FF/UMEC/VI combination improves lung function and quality of life better than Symbicort
Acorda presents data from Phase 1 study of CVT-427 inhaled zolmitriptan
Acorda Therapeutics will present data from a Phase 1 study of its CVT-427 zolmitriptan DPI at the Annual Scientific Meeting of the American Headache Society, the company has announced. According to the company, the data show that the bioavailability of CVT-427 exceeded that of oral and intranasal zolmitriptan with lower variability in plasma concentrations. Acorda, … [Read more...] about Acorda presents data from Phase 1 study of CVT-427 inhaled zolmitriptan
Chiesi reports positive preliminary results from pivotal studies of triple combination MDI
Chiesi says that it is on track with planned regulatory submissions in the EU for its ICS/LAMA/LABA MDI for the treatment of COPD by the end of 2016 after successful completion of two 12-month Phase 3 studies. According to the company, preliminary results from the studies of the extrafine beclamethasone/formoterol/glycopyrronium combination therapy in more than 4,000 … [Read more...] about Chiesi reports positive preliminary results from pivotal studies of triple combination MDI
Pulmatrix completes PK study of PUR0200
Pulmatrix has announced the completion of a Phase 1 pharmacokinetic study of its PUR0200 generic tiotropium DPI in healthy volunteers. Pulmatrix announced the initiation of the study in February 2016. The company has partnered with Mylan on development of PUR0200, which it says is "is focused on demonstrating bioequivalence between PUR0200 and a currently marketed … [Read more...] about Pulmatrix completes PK study of PUR0200
Study shows superiority of Relvar (Breo) Ellipta to usual care in reducing COPD exacerbations
GlaxoSmithKline and Innoviva (formerly Theravance, Inc.) have announced data from the Salford Lung Study (SLS) showing that COPD patients using the Relvar Ellipta 100/25 mcg fluticasone furuoate/vilanterol DPI had an 8.41% lower rate of moderate or severe exacerbations compared to patients receiving LAMAs, LABAs, and/or ICS as monotherapy or in combination. Relvar … [Read more...] about Study shows superiority of Relvar (Breo) Ellipta to usual care in reducing COPD exacerbations
Acorda discontinues development of Plumiaz diazepam nasal spray for seizures
Acorda Therapeutics has announced that clinical trials of Plumiaz diazepam nasal spray have failed to demonstrate bioequivalence to Diastat rectal gel, which means that the company is unable to re-file its 505(b)(2) NDA for the product. The FDA had issued a complete response letter (CRL) for the NDA in 2014. As a result, the company says that it is discontinuing … [Read more...] about Acorda discontinues development of Plumiaz diazepam nasal spray for seizures
Study shows nicotine inhaler helps smokers quit
A study published in the journal Nicotine and Tobacco Research found that 32% of smokers using a nicotine MDI plus a nicotine patch quit for 6 months compared to 18% of smokers using a placebo MDI and a nicotine patch. The study enrolled 502 adults who smoked at least 9 cigarettes per day. According to the authors, "The present trial demonstrates that a simple … [Read more...] about Study shows nicotine inhaler helps smokers quit
NeOnc Technologies initiates Phase 1/2a clinical trial of intranasal perillyl alcohol for glioblastoma
US biotechnology company NeOnc Technologies has announced the initiation of a Phase 1/2a clinical trial of NEO100 intranasal perillyl alcohol (POH) for the treatment of glioblastoma multiforme (GBM), an aggressive brain cancer. Five-year survival for patients with GBM is only 3-5%. The trial is expected to enroll approximately 40 patients in total, and the first … [Read more...] about NeOnc Technologies initiates Phase 1/2a clinical trial of intranasal perillyl alcohol for glioblastoma