Reportedly, Siegfried will carry out all required process transfer and manufacturing at Siegfried’s FDA and DEA registered site in Pennsville, New Jersey.
Commercial manufacture of sodium oxybate is expected to commence after Siegfried obtains the required DEA and FDA approvals and the manufacturing process is transferred from Jazz Pharmaceuticals’ current supplier.
Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of Gaba. Sodium oxybate is the active ingredient in Xyrem (sodium oxybate) oral solution, approved by the FDA and marketed by Jazz Pharmaceuticals in the US for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy.
Walter Kittl, senior vice president and general manager of Siegfried (USA), said: “Sodium oxybate provides an excellent fit with our expertise in the manufacturing of controlled substances and our proven capacity to perform exclusive synthesis. We are excited to work together with Jazz Pharmaceuticals to secure the supply chain of this important drug.”