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Int'l Business Times
a day ago
- Health
- Int'l Business Times
How Neuromodulation is Reshaping the Treatment of Resistant Mental Health Disorders and Restoring Hope
For decades, the landscape of psychiatric care has remained relatively static, dominated by the long-standing and familiar regimen of antidepressants, SSRIs, and psychotherapy techniques. While these continue to be effective for many, there remains a significant segment of the population that grapples with treatment-resistant depression, suicidality, and complex anxiety disorders. With traditional medical interventions rendered ineffective for those suffering from such mental disorders, they're often left feeling like they have no viable options. This absence of hope further exacerbates their condition, often compounding their emotional experience. But now, a quiet transformation has been taking place, bringing a wave of evidence-backed group of therapies, collectively known as neuromodulation, that is changing the reality and offering a breakthrough for patients long left at the margins of traditional care. Michigan Advanced Psychiatry , a mental health treatment clinic that prioritizes patient care over all else, has made it its mission to normalize and expand access to interventional psychiatry and, in doing so, be the beacon of hope for those seeking it. It offers non-invasive neuromodulation therapies such as Spravato (esketamine), IV ketamine infusions, and Transcranial Magnetic Stimulations (TMS). Contrary to popular belief, these modalities are not experimental outliers. They are FDA-approved, protocol-driven interventions with substantial clinical research backing them. And more importantly, they're known to offer rapid, measurable relief to patients who had all but given up on treatment. "Psychotherapy and pharmacology remain the gold standard to start treatment," says Dr. Drew Schmale, co-founder and board-certified psychiatrist at Michigan Advanced Psychiatry. "But when patients haven't succeeded with the traditional course of treatment, and particularly when suicidality is present, continuing down the same path becomes ineffective, and at times, dangerous. That's where neuromodulation needs to be administered much earlier." Ketamine, or ketamine products like Spravato (esketamine), one of the neuromodulation modalities the company has worked with, has shown remarkable efficacy in patients experiencing major depression and acute suicidal ideation. Unlike conventional antidepressants, which often take weeks to stabilize mood, ketamine's effects have the potential to manifest within hours. Its quick results make it an effective crisis intervention tool available in psychiatry today. "When we have an intervention this powerful, withholding it during a psychiatric crisis becomes a question of ethics," Schmale notes. "We shouldn't be okay with allowing people to stay in any state of suffering for long. Ketamine isn't just treating symptoms; it has the power to save lives." Similarly, TMS is another compelling alternative for those seeking non-pharmaceutical interventions. "A lot of people these days are more interested in non-pharmaceutical options that have very minimal side effects," says Dane Reinhart, co-founder of Michigan Advanced Psychiatry. "And TMS is a great answer for that." Unlike Electro Convulsive Therapy (ECT) , which it's often mistaken for, TMS is a non-invasive, outpatient procedure that uses magnetic pulses to stimulate underactive regions of the brain contributing to depression. There's no anesthesia, no systemic side effects, and patients are able to drive themselves to and from the appointment. "It's about a 20-minute session. You walk in, get the treatment, and walk out. The accessibility and minimal disruption to daily life are a game-changer, and our goal has always been to make it widely available," Reinhart states. Access remains central to Michigan Advanced Psychiatry's foundation, and they've developed a multi-faceted approach to bring that to fruition. The treatments themselves are costly, but the clinic works tirelessly to navigate the entire insurance authorization process, securing coverage for patients. In most cases, this results in patients paying only a modest co-pay for their treatments. For those whose insurance coverage is denied, delayed, or unavailable, they remain committed to providing care. Outside of Spravato and TMS, the clinic offers off-label treatment options, such as IV ketamine, to ensure patients can still receive the help they need. To further remove financial obstacles, they provide flexible payment plans tailored to individual circumstances. "We never want cost to be the barrier," Reinhart says. "Our systems are designed to prioritize patient care above all else." The need for these interventions is global. As Schmale explains, "Mental health treatment has been stagnant for decades. We've recycled the same class of medications under different brand names, hoping for different outcomes. Neuromodulation represents the first meaningful leap forward in a generation." And its benefits stretch well beyond depression. While the clinic currently focuses on depressive disorders, anxiety, OCD, and trauma-related conditions, the science behind neuromodulation is already showing promise across a wider psychiatric spectrum, from bipolar disorder to early-stage psychosis. While both Schmale and Reinhart are quick to note that psychotherapy, medication management, and community-based support still hold substantial value, they believe the future of psychiatry will lie in a more integrated, personalized approach, one that knows when to pivot and how to leverage the best available science at the right moment. "What we're trying to do is evolve without abandoning the roots of our discipline," Schmale adds. "This field must move forward responsibly. Otherwise, it's our patients who pay the price for inertia." At Michigan Advanced Psychiatry , that forward motion is not just philosophy, it's a prerogative. As more providers, insurers, and healthcare systems align around the potential of neuromodulation, Michigan Advanced Psychiatry has established that treatment-resistant no longer means untreatable. The tools exist. The data is here. And for the first time in a long time, psychiatry is not just managing illness; it has the ability to heal them.
Mint
02-07-2025
- Health
- Mint
A promising depression drug works. Psychedelics are back.
Positive data on depression treatment based on a drug related to the psychedelic DMT is breathing life into shares of biotechs working on psychedelic medicines, after years of disappointments. Just as top Trump administration health officials have begun to show a more receptive attitude to psychedelics, atai Life Sciences and Beckley Psytech said Tuesday that patients with difficult-to-treat depression symptoms who took Beckley's drug BPL-003 saw improvement in an eight-week trial. Atai is in the process of acquiring Beckley. Patients on a higher dose of BPL-003 had an average decrease of 11.5 points on a rating scale that tracks depression symptoms. That compared with a 5.8 point drop among patients in the control group, who received a tiny dose of BPL-003. The companies will need to continue testing BPL-003. But analysts said Tuesday that based on the results, they see the drug eventually hitting $1 billion in annual sales. 'The dataset should instill confidence in a $1B+ drug," Jefferies analyst Andrew Tsai wrote in a research note. Atai shares were up 24% at midday. Shares of other biotechs working on psychedelic drugs took off as well: Compass Pathwards climbed 13%, while shares of MindMed were up 5.4%. The Beckley drug, BPL-003, is a nasal spray version of the psychedelic 5-MeO-DMT, a close relation to DMT and other similar psychedelics. A long list of biotechs have been looking toward psychedelic medicines in recent years. The aim is to find ways to treat neurological conditions like depression and post-traumatic stress disorder that have proven hard to cure with existing medicines. None have been approved by the Food and Drug Administration so far, though in 2019, Johnson & Johnson received FDA permission to sell a depression medicine called Spravato, which is a derivative of the dissociative anesthetic ketamine. The field hit a major roadblock last summer, when the FDA rejected an application from a private company called Lykos Therapeutics for approval of a treatment protocol for PTSD that combined use of the drug MDMA with talk therapy. At the time, analysts said that other psychedelic treatments might be easier to get approved than Lykos's MDMA treatment, for reasons having to do with the specifics of the Lykos protocol. Now, the positive data from atai and Beckley's drug comes as attitudes within the FDA appear to be shifting in favor of psychedelics. In an interview with the reality show fitness expert Jilian Michaels on NewsNation last month, FDA Commissioner Dr. Marty Makary suggested he was very open to approving psychedelic therapies. 'When I listen to the individuals who have tried some of these for real medical conditions – post-traumatic stress disorder, severe refractory depression – people tell me that they believe that psilocybin was successful, was curative, or significantly helped their severe mood disorder," Makary said. 'I'm saying we have to listen to doctors who have these experiences. And this is one of our top priorities at FDA: To listen to doctors, to listen to patients." Those comments, and similar rhetoric from Robert F. Kennedy Jr., the U.S. health secretary, point to a potentially friendly attitude among regulators toward BPL-003 and similar medicines. In the results announced Tuesday, atai and Beckley said that the two higher dose levels of BPL-003 they tested led to 'statistically significant improvements" in depression symptoms as soon as one day after treatment. The companies said that patients were ready to leave the treatment center two hours after receiving the medication on average. Atai noted that patients who take Johnson & Johnson's Spravato need to stay at their doctor's office for two hours after taking the medicine, which sets a precedent for a similar protocol.
Yahoo
01-07-2025
- Business
- Yahoo
Atai and Beckley, set to merge, reveal study success for psychedelic drug
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Atai Life Sciences and Beckley Psytech are making plans to push the psychedelic drug mebufotenin into Phase 3 testing after it safely and significantly reduced symptoms of treatment-resistant depression in a Phase 2b study. Shares of Atai jumped 20% after the companies' announcement Tuesday. Atai also announced a $50 million private placement in a financing round led by Ferring Ventures and Apeiron Investment, the family office of Atai founder and Chairman Christian Angermayer. With the successful study in hand and a new infusion of cash, the companies are proceeding with plans to merge in the second half of this year. The combination, announced in June, was contingent on positive results from the Phase 2b trial. Atai had previously scooped up a 36% stake in privately held Beckley in 2024. Atai and Beckley are looking to benefit from a new openness to psychedelic drugs for the treatment of mental health conditions. Both Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drug Administration Commissioner Martin Makary have touted the potential benefits of the medicines for patients, while Johnson & Johnson's Spravato, a derivative of ketamine, has generated blockbuster sales. Investors so far have shown a willingness to support the research but are looking for strong results. Compass Pathways recently failed to meet that mark with a medicine that succeeded in a Phase 3 trial but nevertheless disappointed shareholders by only reducing scores on a scale used to gauge depressive symptoms by a mean difference of 3.6 points compared with placebo. Beckley's mebufotenin showed a difference of 5.3 points and 6.3 points for the two therapeutic doses it tested as compared with a low-dose group used as a control when measured at Day 29 after treatment. Wall Street was looking for a difference of at least 5 points, Jefferies analyst Andrew Tsai wrote in a note to clients. Like Spravato, mebufotenin is administered through the nose. Atai and Beckley said participants in its study generally were able to leave the clinic within 90 minutes, which would put the drug in the conventional treatment window established by Spravato. The study also found no serious side effects and no evidence of suicidal intent or behavior in patients given mebufotenin. Researchers tested an 8 milligram dose and a 12 milligram dose against an 0.3 milligram control. The larger difference in depression symptom measurement was in the 8 mg dose, though the companies said they consider efficacy equivalent between the 8 mg and 12 mg doses. They plan to advance the 8 mg dose into Phase 3 testing after consulting with regulators. The companies said improvements were seen as early as one day after treatment and generally lasted at least eight weeks. While the results need to be confirmed in a continuing open-label study of a second dose and the eventual Phase 3 trial, the data suggests Atai and Beckley may be able to offer a longer window between treatments, possibly giving their drug an advantage over rivals such as Spravato, Tsai said. Recommended Reading Compass' big psychedelic study doesn't impress investors
Business Wire
01-07-2025
- Health
- Business Wire
Bay Psychiatric Associates Hosts Open House for Healthcare Providers
SAN MATEO, Calif.--(BUSINESS WIRE)--Bay Psychiatric Associates is excited to announce a successful Open House event at its newly expanded San Mateo location, held on Wednesday, May 7th, 2025. This event welcomed healthcare providers interested in learning more about the clinic's comprehensive mental health services, including Ketamine/Spravato, Transcranial Magnetic Stimulation (TMS), and Outpatient Services such as Psychotherapy and Medication Management. We're thrilled to open our doors to healthcare providers in the community and share the innovative treatments we offer to help individuals manage mental health conditions. Share Founded in 1994, Bay Psychiatric Associates has long been a trusted leader in mental health care in the Bay Area. To meet the growing demand for advanced treatment options, the clinic has expanded its services. The multidisciplinary team, including psychiatrists and dedicated support staff, works collaboratively to ensure patients receive effective, accessible, and compassionate care. The Open House featured guided tours of the facility, opportunities to meet the clinic's medical and administrative staff, and an in-depth overview of the latest in psychiatric care. Hors d'oeuvres and refreshments were provided, and the event also served as a networking opportunity for local healthcare professionals to connect and discuss potential referral partnerships. 'We're thrilled to open our doors to healthcare providers in the community and share the innovative treatments we offer to help individuals manage mental health conditions,' said Dr. Roberto Estrada, Interventional Psychiatry Medical Director at Bay Psychiatric Associates. 'Our team has worked tirelessly to ensure that our services are not only effective but also accessible to those who need them most. We look forward to discussing these advancements with our colleagues in the healthcare field.' About Bay Psychiatric Associates Bay Psychiatric Associates is a leading mental health provider in the Bay Area, specializing in innovative treatments for mental health conditions, including Transcranial Magnetic Stimulation (TMS), Spravato (esketamine), and ketamine therapy. The clinic's multidisciplinary team is dedicated to providing the highest quality care to patients struggling with depression, anxiety, and other mental health disorders. Outpatient clinics are located in Berkeley, San Francisco, Corte Madera, and San Mateo. Learn more via our website.
USA Today
30-05-2025
- Health
- USA Today
Elon Musk, the Trump campaign and ketamine: What to know about the powerful drug
New details about Elon Musk's relationship with ketamine have emerged a few days after the tech entrepreneur announced his departure from the White House. Although Musk had previously mentioned using a "small amount once every other week," the billionaire X owner may have been using ketamine frequently enough on President Donald Trump's campaign trail for the drug to start causing some health issues, according to reporting from The New York Times. Musk previously mentioned using the drug as a medical prescription to treat depression in an hour-long interview with former CNN host Don Lemon in March 2024, where he also denied abusing the drug. Musk is not the only celebrity who has used ketamine. The late actor Matthew Perry was using ketamine under the care of a physician for the treatment of depression, although the levels of ketamine in his system at the time of his death in October 2023 weren't related to his last infusion. Other celebrities who have used the substance include Chrissy Teigen and Sharon Osborne. Here's what to know about ketamine. Need a break? Play the USA TODAY Daily Crossword Puzzle. What is ketamine? Ketamine is a dissociative anesthetic that has some hallucinogenic effects, according to the U.S. Drug Enforcement Administration. It binds to the NDMA receptors and is essentially a 'stop' signal. It starts to interfere with the connection between your brain and your body. The effects are dose-dependent, but it generally leads to a 'disconnected' feeling from you, your person – and your body. Symptoms range from unconsciousness (like when used in general anesthesia) to an 'out of body' experience or hallucinations. Is ketamine legal? Ketamine is a legal medication and is used as an injectable, short-acting anesthetic for use in humans and animals, the DEA says. A ketamine derivative, esketamine under the brand name Spravato, is FDA-approved as a nasal spray to treat depression in adults, according to the National Institute on Drug Abuse. Ketamine has also been used off-label in dozens of clinics across the U.S. to treat other mental health conditions, such as anxiety, in combination with talk therapy. However, most of the ketamine distributed in the U.S. is done so illegally, per the DEA. It's often diverted or stolen from legitimate sources, like veterinary clinics, or smuggled into the country. Ketamine is classified as a Schedule III drug by the agency, which denotes substances "with a moderate to low potential for physical and psychological dependence." In case you missed: Sharon Osbourne says ketamine helped her depression. Is this the next big trend? Short- and long-term effects of ketamine Short-term side effects of ketamine use may include headache, dizziness, sleepiness, feeling strange or 'loopy,' difficulty speaking, numbness, blurred vision or nausea, according to NIDA. Long-term, heavy ketamine use is associated with memory problems, depression and anxiety. The drug may also cause gastrointestinal problems, abdominal pain popularly known as 'k-cramps' and uropathy, which is a blockage in the urinary tract that can lead to infections, or UTIs. Contributing: Delaney Nothaft and Emily DeLetter, USA TODAY.
