Buprenorphine Hydrochloride

AstraZeneca ended a Phase 2 trial of an experimental opioid use disorder treatment, the UK pharma confirmed to Endpoints News . The termination was due to “discontinuation of the AZD4041 clinical development program for OUD,” according to an update on Thursday to the federal clinical trials database. An AstraZeneca spokesperson said via email that there was “a potential drug-drug interaction following a study to examine this risk.” “These data change the potential benefit-risk in this patient population and do not support further development of AZD4041 in opioid use disorder,” the spokesperson added. The oral orexin 1 receptor antagonist entered Phase 2 earlier this year and was still listed on AstraZeneca’s pipeline as of its third-quarter results earlier this month. At the time, the drugmaker said data were anticipated beyond 2025. The study included a drug-drug interaction part testing AZD4041 and a fungal infection drug called itraconazole in healthy participants. Another part of the trial looked at AZD4041 when administered with buprenorphine/buprenorphine and naloxone , an FDA-approved opioid overdose reversal medication. The company had planned to enroll about 100 people, according to earlier records of the trial, but only 15 actually enrolled. Other biotechs are exploring R&D in opioid use disorder, including Aditum’s Tempero Bio, Trevena and Lyndra Therapeutics.

Several telehealth advocates are coming out in support of the Drug Enforcement Administration’s (DEA) third extension of Covid-19 telehealth flexibilities for the prescribing of controlled substances. However, they argue that more work needs to be done to make these flexibilities permanent. The flexibilities, introduced in 2020, permit providers to prescribe some controlled substances virtually without first requiring an in-person visit. These flexibilities were set to expire at the end of the year, but will now expire at the end of 2025 with the third extension announced last week. The issue has been closely followed by many experts, as seen by the 38,000 comments the DEA received in 2023 in response to a set of proposed telemedicine rules that would have rolled back some of the flexibilities allowed during the pandemic. For one telehealth advocate, the extension was a “tremendous relief,” noting that the flexibilities have greatly improved access for underserved communities. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech “It is with a real sense of gratitude that the Drug Enforcement Administration and the Biden administration decided to continue this flexibility that’s now been in place for almost half a decade so that we can continue to take the time to get the permanent framework right. … It was going to be calamitous if we were going to allow for this flexibility to expire December 31 this year,” said Kyle Zebley, senior vice president of public policy at the American Telemedicine Association, in an interview. “Continuity of care would be severed for hundreds of thousands, if not more, patients.” Zebley noted that it is important to prevent abuse of the flexibilities and called for a special registration process that allows medical professionals to register with the agency in order to virtually prescribe controlled substances. Congress mandated the DEA to create this process back in 2008, but the agency has yet to do so. However, he added that instances of inappropriate prescribing “is minuscule compared to the level of access that’s been achieved.” Another telehealth expert — Stephanie Strong, founder and CEO of Boulder Care — echoed Zebley’s comments. Boulder Care offers virtual addiction care, including the prescribing of buprenorphine, which treats opioid use disorder and is included in the telehealth flexibilities. “We anticipated this extension, and celebrate the win as an important step forward. Still, this measure is only temporary: the DEA and HHS continue to make rules that kick the can down the road,” Strong said. “Our country needs strong leadership and a vision for modernizing the healthcare system, which necessarily includes making telehealth a permanent option for millions of Americans who rely on it.” Health IT Reducing Clinical and Staff Burnout with AI Automation As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers. By Dr. Michael Blackman, Chief Medical Officer at Greenway Health Strong added that she wants to see the TREATS Act gain momentum in 2025, which would make telehealth flexibilities permanent for those with opioid use disorder. There is also hope that the Trump administration will introduce a permanent solution to the virtual prescribing of controlled substances, according to Eric Triana, chief compliance officer at Talkiatry. The company offers virtual psychiatry services. “After nearly five years, the benefits of telemedicine services including prescribing without ever having an in-person medical visit has proven to be vital for patients in every state, both rural and urban, due to shortages of mental health providers,” Triana stated. “I anticipate that the new administration will prioritize finalizing a permanent rule with reasonable common-sense safeguards to assist DEA investigators in detecting diversion without interfering with patient access to telemedicine behavioral health services when provided through synchronous audio and video.” Zebley is also hopeful that the Trump administration will create a more permanent telehealth framework before the new extension expires, particularly considering the previous Trump administration first introduced the flexibilities. That said, rulemaking takes time and it’s possible another extension may be needed, he said. Photo credit: Sorbetto, Getty Images