Vancouver-based biotech firm BetterLife Pharma (OTCM:BETRF) is working on a non-hallucinogenic LSD derivative for treating neuropsychiatric and neurological disorders. Known as BETR-001 (2-bromo-LSD), the compound is also not controlled. Conversely, LSD, like other serotonergic hallucinogens, is a Schedule I compound. That status makes it difficult and expensive to research for potential medical uses. BetterLife announced…
Cybin updates on its psychedelic-based therapeutics at R&D Day
Psychedelic therapy company Cybin (NEO:CYBN/NYSE American:CYBN) hosted a virtual R&D Day on February 28, 2023. In the event, the company’s leadership team provided an update on its development pipeline of deuterated psychedelic-based therapeutics, including CYB003 and CYB004. CYB003 is synthetic psilocybin analog, for the potential treatment of major depressive disorder. Cybin provided an interim readout from…
The psoriasis medication apremilast could hold promise in alcohol use disorder
In two animal models, researchers found animals predisposed to mild-to-heavy alcohol use dropped their alcohol intake after taking apremilast, a phosphodiesterase 4 (PDE4) inhibitor. The scientists also tested apremilast in a Phase 2a study involving 51 subjects with moderate-to-severe alcohol use disorder. The subjects reduced their alcohol consumption from an average of five drinks per day…
Psychedelic research firm Lucy Scientific Discovery misses IPO target
Lucy Scientific Discovery Inc. (Nasdaq:LSDI), a Canadian firm that focuses on developing and manufacturing psychotropics-based medicines, had its initial public offering (IPO) today. The company had priced 1,875,000 common shares at a public offering price of $4.00 per share. On its first day of trading, however, the stock dropped by 25.25%, reaching a closing price…
Zuranolone, novel oral medication for depression and postpartum depression, could be on the horizon
Biogen (Nasdaq:BIIB) and Sage Therapeutics (Nasdaq:SAGE) have announced that the FDA accepted the New Drug Application (NDA) for zuranolone, a neuroactive steroid. The drug candidate could be a novel 14-day oral medication to treat Major Depressive Disorders (MDD) or postpartum depression (PPD). Priority review has been granted and the application is slated to be processed…
PsychoGenics CEO explores CNS drug development trends
In the late 2000s, many companies, particularly Big Pharma, exited the field of central nervous system (CNS) drug development and, particularly psychiatry. “Big Pharma exited the space because they were facing their patent cliff at the time and had to make some critical decisions about where to invest their resources,” said Emer Leahy, CEO of…
Terran Biosciences secures intellectual property for psychedelic prodrugs
Terran Biosciences, a neurology and psychiatry-focused startup, has announced the publication of patent applications under the Patent Cooperation Treaty (PCT) for its novel prodrugs of DMT, 5-MeO-DMT and MDMA. Claim of superior pharmacokinetics The company believes the prodrugs have superior pharmacokinetic profiles compared to the unmodified forms of these Schedule I substances. Additionally, it believes…
Yale opens center to study cannabis and cannabinoids
Yale School of Medicine has established a research center, the Yale Center for the Science of Cannabis and Cannabinoids, to investigate how cannabis and cannabinoids affect neurodevelopment and mental health. Led by Dr. Deepak Cyril D’Souza, an expert in cannabinoid pharmacology, the center will use a multidisciplinary approach to study the acute and chronic effects…
MAPS predicts FDA approval for MDMA-assisted therapy in 2024
The Multidisciplinary Association for Psychedelic Studies (MAPS) founder and executive director, Rick Doblin, said in an interview with Fox Business Live that the FDA would approve MDMA-assisted therapy for PTSD in April or May of 2024. Last year, MAPS announced the completion of the MAPP2 Phase 3 study, which is the organization’s second to use MDMA (3,4-methylenedioxymethamphetamine)…
Activist investors pressure MindMed to accelerate clinical development, trim costs
The psychedelic therapeutics market could be worth billions of dollars in the coming years. The FDA has awarded breakthrough therapy designation to psilocybin and MDMA, potentially accelerating its approval of the currently Schedule I substances. Despite the promise, several psychedelic therapeutics companies have seen substantial drops in stock price. For instance, MindMed has seen its…
Add-on Vraylar provides new option for treating major depressive disorder
Traditional antidepressant therapy doesn’t work for all depressed patients. About four out of 10 patients see a noticeable benefit from an antidepressant after six to eight weeks, according to Dr. Arif Khan, a board-certified psychiatrist. For the six out of ten who don’t see a benefit, “the first choice is to switch to a different…
Atai Life Sciences unit GABA Therapeutics upbeat about deuterated form of 1960s drug
The biopharma Atai Life Sciences (Nasdaq:ATAI) subsidiary GABA Therapeutics is sharing positive results from a Phase 1 study of GRX-917, a deuterated form of etifoxine, which the German firm Hoechst developed in the 1960s. Sanofi-Aventis eventually subsumed Hoechst in 2004. Atai investigated the safety, tolerability and pharmacokinetic profile of orally administered GRX-917 in a Phase…
Psychedelic therapy at a crossroads at the dawn of 2023
In several ways, psychedelic therapy continued to make strides toward legitimization in 2022. Michael Pollan’s best-selling psychedelic treatise “How to Change Your Mind” formed the basis for a popular Netflix series. Several celebrities declared that psychedelics had improved their lives. Decriminalization efforts gaining steam Colorado decriminalized psychedelic plants, as did the city of San Francisco.…
How the antidepressant landscape evolved in 2022
One in five people will experience major depressive disorder (MDD) at some point in their lives. Although depression is common, traditional selective serotonin reuptake inhibitors (SSRIs) such as Prozac (fluoxetine) and serotonin-norepinephrine reuptake inhibitors (SNRIs) help about 40–60% of people within six to eight weeks. For those who don’t respond to the first treatment, however,…
Atai Life Sciences’ stock dips after announcing Phase 1 data
Atai Life Sciences (Nasdaq:ATAI) announced inconclusive data regarding the effects of the kratom-derived compound KUR-101 on respiration in a Phase 1 study. The company’s stock was down about 9% in mid-day trading, trading at $2.77. The drug candidate yielded dose-dependent analgesic effects in Part 1 of the study, which assessed the safety and efficacy of various dose…
Vistagen acquires Pherin Pharmaceuticals for its neuroactive steroid pipeline
The biopharma Vistagen (Nasdaq:VTGN) has agreed to acquire privately-held Pherin Pharmaceuticals for roughly 12.4 million shares of Vistagen stock. It will sweeten the deal with “a nominal amount of cash,” the company said in a press release. The deal is subject to customary closing conditions. In October 2018, South San Francisco, California–based Vistagen announced that…
FDA approves cariprazine as an adjunctive treatment for major depressive disorder
AbbVie (NYSE:ABBV) has announced that the FDA has approved Vryalar (cariprazine) as an adjunctive therapy to antidepressants to treat major depressive disorder (MDD) in adults. Cariprazine is a novel atypical antipsychotic drug (APD) that works as a partial agonist at the dopamine D2 and D3 receptors and serotonin 5-HT1A receptors. It works as an antagonist…
How zuranolone could change the antidepressant market
Sage Therapeutics (Nasdaq:SAGE) and Biogen (Nasdaq:BIIB) have filed a rolling NDA submission to the FDA for zuranolone, a potentially novel, rapid-acting, daily treatment for adults with major depressive disorder (MDD) and postpartum depression (PPD). If approved, zuranolone could significantly alter the antidepressant market. A neuroactive steroid, the drug would be prescribed as a 14-day oral…
Why the TAAR1 agonist ulotaront holds promise for schizophrenia
Ulotaront (SEP-363856), a trace amine-associated receptor 1 (TAAR1) agonist in Phase 3 clinical development, could prove to be a breakthrough therapy in treating schizophrenia. In 2020, the New England Journal of Medicine (NEJM) published results from a four-week pivotal study focused on ulotaront, which Sunovion discovered in collaboration with Psychogenics. Ulotaront is the first schizophrenia drug candidate…
Senators Booker and Paul aim to reschedule psilocybin and MDMA to foster research
U.S. Senators Cory Booker (D-N.J.) and Rand Paul (R-KY) have drafted the Breakthrough Therapies Act, which would enable the Drug Enforcement Agency (DEA) to research rescheduling Schedule I drugs such as psilocybin and MDMA to Schedule II. Rescheduling would make it easier for pharmaceutical companies to investigate the therapeutic potential of psilocybin and MDMA. An…
Anesthesiologist opens up on ketamine for depression and anxiety
Physicians, psychotherapists and other health care professionals are collaborating to pioneer strategies to use ketamine to treat mental health disorders, PTSD and chronic pain. One such individual is Dr. Carlos De La Hoz, a triple board-certified anesthesiologist, regenerative medicine and pain-management doctor of the Neomedicine Institute (Doral, Florida). In recent years, the dissociative anesthetic ketamine…
University of Health Sciences Antigua gears up for psilocybin research
The University of Health Sciences Antigua (UHSA) has partnered with Toronto-based Revive Therapeutics (CSE:RVV, USA:RVVTF) to research the potential of psilocybin to help those with addiction. Revive’s focus has increased following its 2020 acquisition of Psilocin Pharma Corp. University of Health Sciences Antigua is currently in the process of obtaining permits to import psilocybin for translational research,…
Why Algernon believes it is the Janis Joplin of psychedelic medicine companies
The Canadian company Algernon (CSE:AGN; Frankfurt:AGW0; OTCQB:AGNPF) is the headline sponsor for the Wonderland psychedelic medicine conference held in Miami from November 3 to 5. Algernon CEO Chris Moreau expects the decision to prominently back the event will raise the company’s profile. “We view Algernon as a Janis Joplin voice singing to a junior high crowd right now,” Moreau…
Why Numinus is developing psilocybin tea for research
Numinus Wellness (TSE:NUMI) has developed a psilocybin-containing tea bag for clinical research and potentially for clients in psychedelic-assisted therapy. The Vancouver–based company’s strategy differs from that of other companies that have popped up in recent years with the intent of creating bespoke psychedelic compounds with patent protection. Some companies, for instance, have created deuterated psilocybin analogs with…
Atai subsidiary wraps up enrollment for clinical study of r-ketamine
Mental health–focused biopharma Atai Life Sciences (Nasdaq:ATAI) recently completed enrollment in a Phase 2a study of PCN-101 (r-ketamine) for treatment-resistant depression. The company’s Perception Neuroscience division expects top-line results from the trial before the end of 2022. R-ketamine is an enantiomer of ketamine. Conversely, racemic ketamine is composed of equal amounts of s-ketamine and r-ketamine.…