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Jazz Pharmaceuticals Announces Orphan Drug Exclusivity for Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution
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Secondary endpoint data for once-nightly FT218 further supports previously announced topline data demonstrating clinically meaningful results at 6 g, 7.5 g, and 9 g doses
DUBLIN, Ireland, April 17, 2021 (GLOBE NEWSWIRE) Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate (ON-SXB) for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the presentation of positive secondary endpoint data at the 2021 American Academy of Neurology Annual (AAN) Meeting being held virtually from April 17-22, 2021. FT218 is currently under review at the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) target date of October 15, 2021.
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Avadel Presents New Data from its Pivotal REST-ON Phase 3 Trial of FT218, once-nightly sodium .
Avadel Pharmaceuticals plcApril 17, 2021 GMT
Secondary endpoint data for once-nightly FT218 further supports previously announced topline data demonstrating clinically meaningful results at 6 g, 7.5 g, and 9 g doses
DUBLIN, Ireland, April 17, 2021 (GLOBE NEWSWIRE) Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate (ON-SXB) for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the presentation of positive secondary endpoint data at the 2021 American Academy of Neurology Annual (AAN) Meeting being held virtually from April 17-22, 2021. FT218 is currently under review at the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PD
Infant Bacterial Therapeutics AB: Infant Bacterial Therapeutics receives additional patent protection in China
Infant Bacterial Therapeutics AB (IBT) today announces that the Chinese patent office has issued a decision to grant approval of IBTs patent application entitled: A method of activating lactic acid bacteria, which protects formulations of
Lactobacillus reuteri including IBP-9414. IBT is currently developing its drug candidate IBP-9414 in Phase III for the prevention of NEC and improvement of feeding tolerance in preterm infants.
The invention covers a novel way to activate the freeze-dried bacteria and corresponding patent applications for the invention are currently pending in additional important future markets including the US and Europe. IBT recently received similar patent protection in Japan. This patent increases the existing protection of IBTs drug candidate IBP-9414 in addition to Orphan Drug Exclusivity and biological data protection already established in the
Investegate |Infant Bacterial Therapeutics Announcements | Infant Bacterial Therapeutics: Infant Bacterial Therapeutics receives additional patent protection in China
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