Soleno concludes serious adverse reported in FAERS not related to VYKAT XR

In a regulatory filing, Soleno Therapeutics (SLNO) disclosed that it is aware that a serious adverse event has been reported in the U.S. Food and Drug Administration’s Adverse Event Reporting System, or FAERS, regarding a patient who is deceased. “The treating physician has reported the case as not related to treatment with VYKAT XR and Soleno’s assessment is the same. This patient was a 17-year-old male with a history of co-morbidities, including lymphedema, superficial thrombophlebitis (treated and followed by a vascular surgery team), and obesity (326 lbs.) who died from an apparent pulmonary embolus. VYKAT XR has a proven safety and efficacy profile and was approved by the FDA following a rigorous clinical program. Like any medication, VYKAT XR should be administered in accordance with its FDA-approved label, which describes anticipated side effects. Soleno Therapeutics is committed to reporting all adverse events experienced by individuals who have taken VYKAT XR in accordance with applicable law. Prader Willi Syndrome is a disease where patients have significant comorbidities and have a markedly reduced life expectancy due to reasons that can include cardiac or respiratory events as well as others such as pulmonary embolism. The mean age of death reported from a 40-year mortality study in the U.S. was 29.5 +/- 15 years (range: 2 months-67 years). Going forward, Soleno does not intend to specifically comment on adverse events cases (including deaths) unless directly related to VYKAT XR use and unexpected per the U.S. Prescribing Information. The existence of a report in the FAERS database does not establish causation,” the company stated.