Camurus announced positive study results for its subcutaneous buprenorphine depot injections (Buvidal) for treating opioid dependence. Lund, Sweden-based Camurus’ 24-week, randomized, controlled trial compared patient-reported outcomes of opioid dependence treatment with subcutaneous weekly and monthly Buvidal depot injections against daily sublingual buprenorphine. Results were published in JAMA Network Open yesterday. “The depot evaluation – buprenorphine […]
Clinical Trials
Oncopeptides completes enrollment in Phase 2 multiple myeloma study
Oncopeptides announced today that it completed patient enrollment for its Phase 2 Port study of its multiple myeloma treatment. Waltham, Mass.-based Oncopeptides’ Port study is an open-label, randomized, crossover study comparing the safety, tolerability and efficacy of peripheral or central intravenous administration of Pepaxto (melphalan flufenamide) in combination with dexamethasone to treat relapsed refractory multiple […]
Vascular Therapies touts surgical stenosis treatment trial despite missed primary endpoint
Vascular Therapies announced today that a Phase 3 clinical trial of its Sirogen sirolimus formulation showed encouraging outcomes. Cresskill, N.J.-based Vascular Therapies designed its Sirogen proprietary sirolimus formulation for intraoperative local drug delivery to reduce surgical stenosis in blood vessels. The Phase 3 clinical trial evaluated Sirogen in elderly end-stage renal disease patients, according to […]
FDA grants breakthrough nod for Fractyl’s type 2 diabetes treatment
Fractyl Laboratories announced today that it received FDA breakthrough device designation for its Revita DMR type 2 diabetes treatment. Lexington, Mass.-based Fractyl’s Revita DMR treatment is an outpatient endoscopic procedure designed to resurface the upper intestine lining (duodenal mucosa) in metabolic disease for patients with insulin-treated type 2 diabetes. Preliminary clinical findings suggest that the […]
Delpor doses first patient in once-yearly risperidone implant trial
Delpor announced today that it dosed the first patient in a Phase 1b/2a clinical trial for its DLP-114 risperidone implant. DLP-114 is a long-acting formulation of the antipsychotic risperidone for schizophrenia maintenance therapy. The open-label study is to evaluate the safety, tolerability and pharmacokinetics of switching from oral risperidone to the once- or twice-yearly DLP-114 […]
Cure Pharmaceutical touts data from Curefilm Blue trial for erectile dysfunction
Cure Pharmaceutical announced today that it observed positive results from a trial for its Curefilm Blue platform. Oxnard, Calif.-based Cure touted the results of its initial pharmacokinetics (PK)/bioequivalence studies ahead of the advancement of its clinical program in pursuit of FDA approval, according to a news release. The company did not reveal the specific data, […]
Medtronic touts 2-year study results for In.Pact AV drug-coated balloon
Medtronic (NYSE:MDT) today touted safety and effectiveness results from a 24-month study of its In.Pact AV drug-coated balloon. Fridley, Minn.-based Medtronic said in a news release that the data demonstrated that the In.Pact AV DCB is the first and only DCB to show sustained and superior effectiveness through two years compared to standard percutaneous transluminal […]
D&D Pharmatech to collaborate with Yale on brain cancer therapies
D&D Pharmatec announced today that it is collaborating with Yale to optimize two approaches to treating brain cancer and other disorders. The sponsored research agreement is slated to work with two novel approaches that allow immune system cells and drug molecules to bypass the blood-brain barrier (BBB) when treating brain cancer, among other diseases, according […]
Once-a-week insulin dosing shows promise in studies
Studies suggest that a new once-per-week injectable insulin therapy is safe and as effective as daily injections for those with type 2 diabetes. Two international clinical trials published today in Diabetes Care found that the once-weekly treatment has the potential to offer a convenient alternative to daily insulin shots for those with type 2 diabetes, according […]
Lyndra Therapeutics touts Phase 2 data for oral schizophrenia treatment
Lyndra Therapeutics yesterday announced positive results from a Phase 2 study of its once-weekly, oral schizophrenia treatment. Watertown, Mass.-based Lyndra’s oral, long-acting, extended-release risperidone capsule, LYN-005, is designed for the weekly treatment of schizophrenia. Data from the company’s first repeat-dose Phase 2 study demonstrate that LYN-005 offered sustained therapeutic levels of risperidone over the one-week […]