Alprazolam

Praxis reported that its lead small molecule program failed a Phase 3 study on Friday morning, sending its stock price $PRAX down roughly 40%. The company was studying whether an experimental drug called ulixacaltamide could treat patients with essential tremor, a nervous system disorder that causes involuntary shaking. Typically, patients are treated with beta blockers or antipsychotic medications like Xanax, but ulixacaltamide is designed to inhibit T-type calcium channels. In a press release, Praxis said the trial’s independent data monitoring committee recommended the study stop early due to a high likelihood of futility. The primary endpoint was unlikely to be reached, the company said. But Praxis said it intends to complete the study, as well as another Phase 3 looking at the randomized withdrawal of ulixacaltamide, because the committee also “indicated that some underlying assumptions of the statistical model might have influenced this outcome.” Topline results for both trials are expected in the third quarter, after which Praxis will make a decision about whether to file for approval with the FDA. It wasn’t immediately clear what such underlying assumptions were or how they might have influenced the data. Praxis didn’t immediately return a request for comment. In a note to investors last month, TD Cowen analyst Ritu Baral said Praxis had intended to complete the trial regardless of the data committee’s findings. A futility finding likely would indicate “minimal to no separation” between ulixacaltamide and placebo, she added. Despite Friday’s fail, Praxis’ small molecule platform will continue to produce data readouts this year. The company is expecting open-label data for the epilepsy program vormatrigine in the first half of 2025, as well as Phase 2/3 data in the second half of the year.

For about half a decade now, Americans have had the ability to receive controlled substances via telehealth because requirements were relaxed during the Covid-19 pandemic. This has greatly expanded access particularly for those in remote areas. These flexibilities are currently set to expire at the end of 2025. In the final days of the Biden administration, the Drug Enforcement Administration released three new rules relating to telemedicine that aim to keep some of these flexibilities permanent while also implementing new safeguards to promote patient safety. “DEA’s goal is to provide telehealth access for needed medications while ensuring patient safety and preventing the diversion of medications into the illicit drug market,” said former DEA Administrator Anne Milgram in a statement. “We understand the difficulties some patients have accessing medical providers in-person, and we want to ease this burden while also providing safeguards to keep patients safe.” presented by Artificial Intelligence What Keeps Healthcare CIOs Up at Night: Balancing Technology Investments with Consumer Expectations When it comes to managing inbound phone calls, underperformance has devastating cost implications. By Stephanie Baum This effort, however, has telehealth advocates up in arms, particularly in regards to two of the three proposals, which they argue include arbitrary guidelines that interfere with the clinician’s job and create barriers for patients. Now, via statements, they are calling upon the Trump administration to make things right. One is a proposed rule that would create a special registration process that would allow a clinician to prescribe medications through telemedicine visits without an in-person evaluation. While that sounds reasonable, there are significant restrictions, including requiring physicians to be physically located in the same state as the patient when being prescribed Schedule II medications. Schedule II medications are drugs that have a high potential for abuse, including Adderall and Ritalin. The second rule permits patients to receive a six-month supply of buprenorphine (used to treat opioid use disorder) via telehealth, but would require an in-person visit after. The third rule, however, actually seems to expand access to telehealth by exempting Veterans Affairs practitioners from special registration requirements. After a patient has had an in-person medical examination from a VA medical practitioner, “the provider-patient relationship is extended to all VA practitioners engaging in telemedicine with the patient,” according to the DEA. The new rules are less restrictive than a previous proposed rule released in 2023. Still, many advocates argue that these rules were rushed by the previous administration and will only create barriers to access. Healthcare Using Data to Help Healthcare Practices Succeed A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices. By Relatient “One of the challenges that so many in the community have with the first proposal the DEA made, and even the second one is that it continues to really bleed into medical judgment and the relationship between a practitioner and a patient,” said Christopher Adamec, executive director of the Alliance for Connected Care. “It limits the care that can be provided. It puts practitioners in really unfortunate situations of being able to provide some care, but maybe not the care that they think is clinically appropriate for their patient. That is not the right way for these rules to move forward.” Special registration rule Under the special registration rule, special registration would be available to medical providers treating patients who require Schedule III-V controlled substances, such as ketamine, Xanax and Lomotil. Special registration would also be available for Schedule II medications if the medical practitioner is board certified in one of these specialities: “psychiatrists; hospice care physicians; physicians rendering treatment at long term care facilities, and pediatricians for the prescribing of medications identified as the most addictive and prone to diversion to the illegal drug market,” according to the DEA. The American Telemedicine Association (ATA) has concerns — three that are tied to the special registration proposed rule, according to Kyle Zebley, senior vice president of public policy at the association. One is that practitioners can only prescribe less than 50% of Schedule II controlled substances via telemedicine, and the rest would have to be in person. Zebley argues that this threshold is “arbitrary and clinically inappropriate,” and that there is no medical reason that this is needed. The rule would also require the provider to be in the same state as the patient when prescribing Schedule II controlled substances. “That doesn’t allow for the full potential of telehealth. That would be a massive backwards step in terms of the level of access that’s been achieved now for half a decade,” Zebley said. Adamec of the Alliance for Connected Care echoed this, stressing that the “promise of telehealth” is creating access for people who don’t have in-person access to care, such as if they’re in a mental health shortage area or in a rural community. In addition, the special registration rule would require practitioners to conduct a Prescription Drug Monitoring Program (PDMP) check of all 50 states. A PDMP is an electronic database that tracks controlled substance prescriptions and allows practitioners to see patients’ prescribed medication history. Currently, providers can check PDMP records on a state-by-state basis. However, in three years, the DEA envisions a provider checking all 50 states’ PDMP records for all controlled substances, and this is currently challenging, according to Zebley. “That is not something the federal government can mandate,” he said. “It requires state governments to comply, and some states are obviously very protective of this. There’s no single, unified database to do this, it’s very time intensive. So you can’t do it, and if you could, there’s no easy way to do so.” One digital health executive noted that it would be great if there was a way to do a national check of PDMP records, but agreed that there is no feasible way to do it today. “I don’t even know who would undertake [a national PDMP database],” said Robert Krayn, CEO and co-founder of Talkiatry, a virtual psychiatry company. “There’s no pathway. It just says, ‘Oh, you’ve got to check it nationally.’ But there is no one even working on this, to my knowledge. Where’s the money coming from, who’s working with all the states? What is the technology? This is like starting at zero. This rule doesn’t require anybody to actually create the database.” The buprenorphine rule Telehealth advocates also have concerns with the buprenorphine final telemedicine rule, which would allow a patient to receive a six-month supply of buprenorphine through telephone consultation. Additional prescriptions of buprenorphine would require an in-person visit. “Stopping something at an arbitrary period after six months is concerning,” Krayn said. “Patients become opioid naive at that point in time. And so if you cut off their access and they go back to using substances, it could have a material effect on an increase in overdoses.” This rule could greatly disrupt care for someone who is struggling with a substance use disorder, noted T.J. Ferrante, partner and a board-certified healthcare lawyer with Foley & Lardner LLP. “This is a vulnerable population,” he told MedCity News. “Buprenorphine is for substance use or opioid use disorders, and especially with the timeline of six months, they’re still in the early stages of that medication, treatment, management and care. … To all of a sudden require these individuals to have to go somewhere could be very disruptive.” What’s next The ATA has put out a call that the Trump administration withdraw the proposed special registration rule and make the remote prescribing of controlled substances permanent. Specifically, Zebley of the ATA wants the 50% threshold for Schedule II drugs removed, as well as the geographic barriers requiring clinicians to be in the same state as the patient. He also wants the requirement of checking national PDMP records to be made more “manageable.” Ferrante called for similar changes and noted that he’s optimistic the rule will be withdrawn or modified. When it comes to the buprenorphine rule, the Alliance for Connected Care wants it to be reworked or pulled back. That said, getting a six-month supply of buprenorphine via telemedicine is better than nothing, according to Adamec. Ultimately, he hopes to see the DEA not interfere with clinical care. “I would like to see either Congress or the administration move forward with a law enforcement-focused approach that creates a capability for the DEA to monitor the sector, understand exactly what’s happening and take the action that it needs to take against bad actors if they are detected,” he said. “But we don’t necessarily need a bunch of micromanagement of how clinicians and patients should be able to interact when providing care.” While many telehealth advocates are against the new rules, at least one digital health executive considers them to be a good thing. “Maybe it’s a little bit more red tape, but honestly, in the last few years, I think VC-fueled digital health has been a little bit too fast and loose in prescribing, given the high growth profit incentives as VC-backed companies,” said Sean Mehra, founder and CEO of HealthTap. “So I don’t mind a little bit of tension on the other side, because while these VC-backed companies may complain of slightly constrained profits in the short term, for sure the thing that will kill them in the long term is compromising patient safety.” While Mehra declined to give specific examples, one company that made headlines was Cerebral, a mental health company that came under federal investigation for its prescribing practices of controlled substances, including Adderall. Ultimately, Cerebral providers stopped prescribing them. HealthTap is a virtual primary care company. It’s worth noting that the company has a clinical policy to not prescribe controlled substances. Krayn of Talkiatry, the digital psychiatry company, likely disagrees. He believes the rules as written will only jeopardize patient care. “I don’t think they actually add any guardrails, and the guardrails that [the DEA] did put in are just barriers to access above anything,” he argued. “There’s a lot that’s wrong with it. And ultimately, if it goes through, it will just harm patients.”