AtaiBeckley, a biopharmaceutical research company headquartered in the Netherlands, announced last Monday, November 10, that it had obtained positive results in a Phase 2 study involving BPL-003, a patented bufotenin benzoate formulation in the form of an intranasal spray with antidepressant effects. The results now announced reinforce the safety and efficacy of a second dose in patients with treatment-resistant depression.
Read the full article HERE.
What are the effects of this psychedelic?
In this second phase of the clinical trial, a 12-milligram dose of BPL-003 administered eight weeks after an initial dose of 12, 8, or 0.3 milligrams produced additional, rapid, and clinically relevant antidepressant effects that persisted for up to eight weeks.
Patients who had received an active dose of BPL-003 in an earlier phase achieved higher rates of response and remission from depression after receiving a 12-milligram dose in this second phase, with 63% showing a response and 48% in remission by the eighth week.
These results are being released after the Food and Drug Administration (FDA) designated BPL-003 as a breakthrough therapy for the treatment of treatment-resistant depression. The next step is to work with the U.S. agency to prepare for the third phase of the study.
“These new data convincingly reinforce that re-administration of BPL-003 may offer additional and lasting antidepressant effects in patients with treatment-resistant depression, while maintaining a favorable safety and tolerability profile,” said Srinivas Rao, CEO and co-founder of AtaiBeckley, as quoted in a press release.
“It is particularly noteworthy that two doses, administered eight weeks apart, produced antidepressant effects that lasted up to four months. These results support the feasibility of a treatment regimen involving intermittent doses and a short psychedelic experience, which could be easily integrated into the current healthcare infrastructure and reduce the impact on patients and healthcare professionals,” he adds.
“Given the urgent need for more effective therapies, our priority—following our Phase 2 completion discussions with the FDA—is to move BPL-003 into Phase 3 clinical trials, with the goal of making this promising treatment option available to patients as soon as possible,” he concludes.
How does intranasal administration of psychedelics work?
The intranasal administration of psychedelics for the treatment of depression is not a new concept. In Portugal, particularly at The Clinic of Change, a medication called Spravato (escetamine hydrochloride) is already in use. It is indicated for Major Depressive Disorder in adults who have not responded adequately to at least two antidepressants administered at doses and for durations appropriate for treating treatment-resistant depression.
Read more about our treatment program for depression, anxiety, and post-traumatic stress using ketamine-assisted psychotherapy HERE.
