US drugmaker Lykos Therapeutics is reducing most of its employees after the Meals and Drug Administration rejected its MDMA drug for psychological well being remedies.
Lykos will lay off 75% of its employees, or about 100 workers, and the remaining workforce will give attention to ongoing growth and dealing with the FDA, the corporate stated in an announcement on Thursday. Its founder, Rick Doblin, can even exit the privately-held firm’s board.
“As we put together to handle the FDA determination, we have to give attention to delivering the FDA the sturdy scientific information essential to help the approval of this potential new remedy,” Amy Emerson, the CEO of Lykos, stated within the assertion.
The corporate stated it’s planning to resubmit its analysis to the FDA as a result of it believes that MDMA, which can also be generally often known as ecstasy or molly, can assist individuals with post-traumatic stress dysfunction, together with veterans and survivors of sexual violence.
That is the primary time the company has thought-about a psychedelic for medical use.
If the FDA dominated in its favor, Lykos had the potential to develop into a multibillion-dollar firm.
Johnson & Johnson sells an esketamine nasal spray referred to as Spravato for melancholy. It is one of many few new remedies for psychological sickness authorised in recent times, and it had international gross sales of about $500 million within the first half of the 12 months, per the corporate’s newest financials.
MDMA is a Schedule I drug underneath the Managed Substances Act, together with heroin and hashish. The classification is given to medication with a excessive potential for abuse and no presently accepted medical use in remedy in america, in keeping with the Drug Enforcement Administration.
Potential results of utilizing MDMA embody melancholy, nervousness, and paranoia, whereas overdose results embody coronary heart and liver failure and dying, per the DEA.
