While not as life threatening as cancer or HIV, narcolepsy remains a poorly treated condition that afflicts approximately 200,000 Americans and 3 million people globally. In the US, narcolepsy is treated primarily with Xyrem, a sodium oxybate formulation with $1.6 billion in sales.
Narcolepsy sufferers fall asleep uncontrollably during the daytime, but researchers believe the daytime episodes can be mitigated with better sleep during the night. Ironically, Xyrem is administered two times to produce better sleep, with the first dose at bedtime and a second dose 2.5 hours to 4 hours later, thereby interrupting the sleep pattern.
Avadel Pharmaceuticals, which was formed through a combination with Lyon, France-based Flamel Technologies, recognized the problems with Xyrem. It applied Flamel’s micropump drug delivery technology to sodium oxybate to create FT218, which would require only one dose taken at bedtime.
SanaCurrents assigned a pivotal sentiment on September 25, 2019 to a positive outcome for Avadel’s phase III trial of FT218. Results of the phase III trial were expected in the second quarter of 2020.
In February 2020, a group of institutional investors likewise recognized the potential of FT218. The institutional investors made a $65 million private placement in Avadel, sending the company’s shares to $10.64 per share from $4.34 per share when the SanaCurrents report was issued in September 2019.
By the time Avadel disclosed the positive phase III results on April 27, 2020, the company’s stock traded at $13.49 per share, a 211% increase from September 2019.