Shots: NICE has issued a positive Final Appraisal Document which recommends Sunosi (75/150mg, qd) as an option treatment for adults with EDS caused by narcolepsy with/out cataplexy. The therapy will […]readmore
Tags : Narcolepsy
Shots: Harmony to receive $3.5M up front & development and regulatory milestone along with royalties & will acquire full development and commercialization rights globally, Ex- Greater China The acquisition of […]readmore
Shots: The P-III study involves assessing Xywav vs PBO in patients aged ≥ 7yrs. with cataplexy or EDS with narcolepsy Results: study met its 1EPs & 2EPs i.e. differences in […]readmore
Regulatory
Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates) Receives
The FDA approval is based on P-III study results assessing Xywav vs PBO in 201 patients to evaluate the safety and efficacy in the treatment of cataplexy and EDS in […]readmore
Shots: The MAA is based on four studies included in TONES program assessing Sunosi (75mg/150mg or 37.5mg, 75mg and 150 mg) vs PBO in 900+ adults with EDS associated with […]readmore
Shots: The approval is based on P-II/III EXPRESS study assessing Xyrem vs PBO in patients with narcolepsy with cataplexy aged 7-17 yrs. P-II/III EXPRESS study results: @2 wks. change in […]readmore
Shots: The US FDA’s ODD may enable Axsome a seven years of marketing exclusivity in the US, with incentives and reduction in user fees of product required for PDUFA act […]readmore