Soleno Therapeutics recently announced new findings regarding its investigational drug VYKAT™ XR (diazoxide choline extended-release tablets) for the treatment of Prader-Willi syndrome (PWS), as detailed at GlobeNewswire. The data, which was presented at a scientific meeting, focused on the effects of resuming VYKAT™ XR treatment in patients who had experienced a withdrawal period during a clinical study.
Prader-Willi syndrome is a rare and complex genetic disorder often characterized by insatiable hunger, leading to obesity, as well as behavioral and intellectual challenges. Managing hyperphagia, or excessive hunger, is a critical unmet need in PWS, as there are currently no approved therapies specifically targeting this symptom.
The study involved a randomized withdrawal period during which patients who had been receiving VYKAT™ XR were switched to placebo. After this period, patients were allowed to resume VYKAT™ XR treatment. The results showed that resuming VYKAT™ XR led to significant improvements in hyperphagia-related behaviors and symptoms compared to those who remained on placebo. These findings suggest that VYKAT™ XR may help manage one of the most challenging aspects of PWS.
The data presented reinforces previous clinical evidence supporting the efficacy and safety of VYKAT™ XR in individuals with Prader-Willi syndrome. The study’s design, specifically the randomized withdrawal and subsequent resumption of treatment, helped demonstrate that the observed improvements were directly attributable to VYKAT™ XR and not to other factors.
Soleno Therapeutics’ CEO, Dr. Anish Bhatnagar, was quoted in the article expressing optimism about the results, emphasizing the urgent need for effective therapies for PWS. He highlighted that the ability to reverse the deterioration in symptoms following withdrawal by reintroducing VYKAT™ XR further underscores the drug’s potential as a targeted intervention for hyperphagia in PWS.
The article also notes that these latest findings will be instrumental in further discussions with regulatory agencies as Soleno Therapeutics continues its efforts to bring VYKAT™ XR to patients. The company’s ongoing clinical development program aims to address the significant unmet medical needs of the PWS community and improve the quality of life for patients and their families.
