Soleno Therapeutics presented positive clinical data from its ongoing late-stage Diazoxide Choline Extended-Release (DCCR) development program for the treatment of patients with Prader-Willi syndrome (PWS). The patients were treated in C601, a Phase 3 randomized, double-blind, placebo-controlled study and C602, its ongoing open-label extension. Following one year of treatment with DCCR, significant hormonal, cardiometabolic and body composition changes were observed in PWS patients. The data were presented by Dr. Eric Felner, Emory University School of Medicine at the 2022 Endocrine Society Annual Meeting & Expo (ENDO).
REDWOOD CITY, Calif., Jan. 24, 2022 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno or the Company) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided an update following recent interactions with the U.S. Food and Drug Administration (FDA) regarding the development of once-daily DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS).
REDWOOD CITY, Calif., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced top-line results from the Company’s ongoing open-label extension study, C602, evaluating investigational, once-daily DCCR (Diazoxide Choline) Extended-Release tablets for patients with Prader-Willi syndrome (PWS) and its comparison to data from the PATH for PWS natural history study.
REDWOOD CITY, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that body composition data from the Company’s Phase III trial, DESTINY PWS (C601), evaluating once-daily Diazoxide Choline Controlled Release (DCCR) tablets for patients with Prader-Willi Syndrome (PWS), will be highlighted in a late-breaking oral presentation at The Obesity Society’s ObesityWeek® 2020 meeting, being held virtually from November 2-6, 2020. The data will be presented by Parisa Salehi, M.D., Clinical Director of the Prader-Willi Syndrome Clinic at Seattle Children’s Hospital.
Soleno Therapeutics (SLNO +18.8%) announces updated top-line results from Phase 3 trial DESTINY PWS (C601), evaluating once-daily Diazoxide Choline Controlled Release (DCCR) tablets for the treatment of Prader-Willi Syndrome (PWS). Data were highlighted at the Foundation for Prader-Willi Research Annual Research Symposium.
Novitium Pharma`s Generic Diazoxide Receives Approval in US
e5 Pharma's Generic Diazoxide Receives Approval in US
e5 Pharma, LLC., today announced the U.S. launch of Diazoxide, USP Oral Suspension, the first generic version of the reference listed drug, Proglycem®. e5 Pharma received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) using the Competitive Generic Therapy (CGT) Pathway.
The strain was evident in Alireza Karimi’s voice as he described his struggle to obtain the diazoxide pills his father needs to lower insulin levels and fight pancreatic cancer.
The strain was evident in Alireza Karimi’s voice as he described his struggle to obtain the diazoxide pills his father needs to lower insulin levels and fight pancreatic cancer.