On the heels of positive phase II results of its extended-release ketamine (R-107) in treatment-resistant depression, Douglas Pharmaceuticals Ltd. is gearing up to begin phase III trials of its ketamine treatment that is safe enough to take at home without clinical supervision.
On the heels of positive phase II results of its extended-release ketamine (R-107) in treatment-resistant depression, Douglas Pharmaceuticals Ltd. is gearing up to begin phase III trials of its ketamine treatment that is safe enough to take at home without clinical supervision.
“The development of psychedelic medicines should adhere to the current European regulatory framework, at both the pan-European and member state level. It is imperative that developers understand and thoroughly apply the regulatory guidance and requirements that are in place.” That was the somewhat discouraging opening statement at the stakeholder workshop convened by the EMA to discuss the development and therapeutic use of psychedelic substances to address unmet medical needs in the area of mental health.
Mira Pharmaceuticals Inc. has entered into a licensing agreement with Miralogx LLC for exclusive rights in the U.S., Canada and Mexico to develop and commercialize Ketamir-2, a novel oral ketamine analogue for depressive disorder treatments.
The British Museum in London, steeped in history and tradition, sits alongside world class biomedical and clinical research centers, where numerous technological advances and scientific breakthroughs have originated. “This unique combination of tradition and innovation […] also defines our industry today,” said Rivki Stern, co-founder and CEO of Shortwave Pharma Inc., which is working to develop psychedelic drugs as approved medicines that meet unmet medical needs of patients with treatment-resistant depression, addictions and eating disorders.
Beckley Psytech Ltd. is advancing lead BPL-003 psychedelic therapy on two fronts, opening phase IIa trials in alcohol use disorder and in treatment-resistant depression.
Beginning July 1, Australia’s Therapeutic Goods Administration will allow medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for certain mental health conditions.
Over the past few years, the pandemic clearly has put a spotlight on vaccines and the infectious disease space. But the struggle to adjust in COVID-19’s wake also brought into stark relief another high unmet need. “Coming out of COVID, there was a mental health focus coming into play,” said Andrew Levin, partner and managing director at investment firm RA Capital Management who is also serving as interim CEO at Lusaris Therapeutics Inc., a 2021 startup targeting neuropsychiatric and neurological conditions, with an initial focus on treatment-resistant depression.
Compass Pathways plc is poised to start the first ever phase III trial of the psychedelic drug psilocybin, after getting U.S. FDA backing for a study in treatment-resistant depression.
