Biocodex Develops DIACOMIT® Oral Suspension for Pediatric Dravet Syndrome Treatment

Biocodex, a global pharmaceutical company known for its pioneering work in treating rare pediatric diseases, has announced a significant development in the treatment of Dravet syndrome. The company is developing a new oral suspension formulation for DIACOMIT, an FDA-approved medication designed to manage seizures associated with this severe form of epilepsy. This new formulation will be intended for patients aged six months and older, weighing at least 15 pounds, who are also taking clobazam. The innovation is being developed at Biocodex's Research and Development (R&D) center in France and represents a major advancement for young patients with this challenging condition.

The new oral suspension formulation of DIACOMIT is a result of extensive research conducted over several years by Biocodex's R&D team. This development highlights the company's ongoing dedication to addressing the needs of patients with rare diseases, particularly in the area of pediatric epilepsy. Biocodex has been at the forefront of improving care for children with Dravet syndrome, having led the first clinical trial for this condition. Through continuous research and innovation, Biocodex aims to enhance the quality of life for affected children and their families.

Caroline Schreiner, Vice President of Global Orphan Diseases at Biocodex, emphasized the company's commitment to providing innovative solutions for children with Dravet syndrome. "At Biocodex Orphan, our priority is to improve the quality of life for children affected by Dravet syndrome and their families at every stage of comprehensive care. This new development is a concrete testament to our commitment to providing innovative solutions tailored to children suffering from this syndrome," Schreiner stated.

Biocodex Orphan has consistently reaffirmed its commitment to expanding its portfolio of treatments for rare pediatric diseases. The company focuses particularly on neuropediatrics through various partnerships and innovative solutions.

Currently, DIACOMIT is available in capsules and sachets in over 55 countries. The introduction of the oral suspension formulation is expected to better meet the needs of younger patients, especially infants with low body weight, those who have difficulty swallowing capsules, or those who require precise dose adjustments. This new formulation will make administration easier and more suitable for patients and caregivers in the Dravet community.

Beyond treatment solutions, Biocodex is dedicated to raising awareness about rare epilepsies. The company works alongside healthcare professionals, patients, and caregivers to provide comprehensive care and innovative services to the Dravet community, positioning itself as a trusted partner in their journey.

Dravet syndrome is a rare and severe genetic epilepsy that typically begins before the age of one. Affected children, who initially develop normally, start experiencing frequent, prolonged seizures. These seizures can cause lasting damage, leading to developmental and cognitive delays, affecting coordination, language, and behavior. The incidence of Dravet syndrome is estimated to be one in 16,000 births.

Founded in 1953, Biocodex is a French family-owned pharmaceutical company that places health at the core of its initiatives and innovations. The company is a leader in human microbiota health and has developed its activities around three strategic areas: microbiota, women's health, and orphan diseases. Biocodex has also expanded its expertise to include pain management, respiratory and ENT pathways, and neurology. The company operates in 115 countries and emphasizes its territorial roots, producing in France for over 50 years.

Biocodex's global organization consists of 1,700 employees who share common values and are dedicated to their mission. They are committed to improving the lives of patients worldwide through innovative solutions and comprehensive care.