HealthDay News — The US Drug Enforcement Administration on Wednesday issued a 6-month extension for people seeking to fill controlled medication prescriptions via telehealth. That ability had been set to expire along with the ending of the pandemic public health emergency on May 11.

“These medications, including those used to treat opioid use disorder, are a vital form of care for millions of Americans who have come to rely on safe and effective telemedicine appointments,” Bobby Mukkamala, MD, chair of the American Medical Association Substance Use and Pain Care Task Force, said in a statement. “Patients being treated with these medications often have challenges securing and traveling to in-person appointments. We are grateful the DEA is approaching this issue with the gravity it deserves, and we look forward to reviewing the details of the policy when they become available.”

Prior to the pandemic, patients had to see a doctor for at least one in-person appointment before being able to access prescriptions for a long list of medications, including stimulants for attention-deficit/hyperactivity disorder, benzodiazepines for anxiety, and medications for opioid use disorder, sleep, or pain.

The DEA had offered proposals on March 1 that would allow prescribers to prescribe one 30-day supply of these controlled medications or the opioid use disorder buprenorphine without an in-person exam. Then an exam would be required before the next prescription. In the public comment period ending in March, the DEA received 38,000 messages about the proposals. The extension through November 11, 2023, gives the DEA and the US Department of Health and Human Services the chance to consider the revisions and the public comments.

“We take those comments seriously and are considering them carefully,” DEA Administrator Anne Milgram said in an agency news release. “We recognize the importance of telemedicine in providing Americans with access to needed medications, and we have decided to extend the current flexibilities for 6 months while we work to find a way forward to give Americans that access with appropriate safeguards.”

The extension also allows that “if a patient and a practitioner have established a telemedicine relationship on or before November 11, 2023, the same telemedicine flexibilities that governed the relationship to that point are permitted until November 11, 2024,” according to the DEA.

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Topline results were announced from a phase 3 study evaluating fasedienol (PH94B) nasal spray in adults diagnosed with social anxiety disorder (SAD).

Fasedienol is a first-in-class, rapid-onset investigational pherine nasal spray. The double-blind, placebo-controlled PALISADE-2 trial (ClinicalTrials.gov Identifier: NCT05011396) included 141 participants who were randomly assigned to receive fasedienol (n=70) or placebo (n=71) intranasally 20 minutes before a public speaking stressor. Patients had marked social anxiety at enrollment, with a baseline score on the Liebowitz Social Anxiety Scale (LSAS) of at least 70. The primary endpoint of the study was the difference in patient-reported Subjective Units of Distress Scale (SUDS) score during the public speaking challenge.

Findings showed that treatment with fasedienol resulted in a statistically significant difference in average SUDS score during a public speaking challenge compared with placebo (difference between groups of -5.8; P =.015). The trial also met its secondary endpoint with 37.7% of fasedienol-treated patients rated as responders (as measured by the Clinical Global Impression-Improvement scale) vs 21.4% of those who received placebo (P =.033). The treatment was reported to have a favorable safety profile consistent with prior trials.

“Fasedienol demonstrated a rapid and very clinically meaningful reduction in SUDS score, indicating a single administration has the potential to reduce anxiety symptoms during an anxiety-provoking situation,” said Dr Michael R. Liebowitz, innovator of the LSAS, former Columbia University psychiatrist, director and founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute, and current Managing Director of The Medical Research Network LLC in New York City. “A future phase 3 study involving multiple administrations of fasedienol over several weeks on a patient-tailored, as-needed basis will build on the body of evidence now demonstrated in PALISADE-2 and multiple phase 2 studies.

According to Vistagen, the PALISADE-2 trial has been stopped due to business reasons. Additional analysis of the data is ongoing and will be presented at a future medical meeting.

The device is designed to transcutaneously deliver low-level electrical stimulation to the skin behind the ears, over the mastoid processes, through 2 self-adhesive electrode pads. The treatment is delivered for a period of 30 minutes before bed; users can engage in other activities while using the device. The prescription device includes a Modius headset, 150 electrode pads (enough for approximately 3 months use), alcohol cleansing wipes, and a micro USB charging cable. 

According to the Company, the clearance was granted based on data from two phase 3 trials conducted by Ulster University in the UK and Ireland and the Indian Center of Neurophysiology in India. Both were randomized, double-blind, sham-controlled trials that included patients diagnosed with generalized anxiety disorder. 

In the UK study, participants were instructed to use their allocated devices for 30 minutes per day for a 4-week duration at home. Results showed more patients in the Modius Stress group achieved a 4 point or more reduction in Generalized Anxiety Disorder (GAD)-7 score from the baseline visit to the week 4 visit compared with the sham group (75% [27 out of 36] vs 51% [20 out of 39], respectively). The Modius Stress group had a reduction of 5.41 in GAD-7 score vs a reduction of 3.96 in the sham group.

Similar results were seen in the India study, where participants were asked to complete 20 sessions (30 minute duration) approximately 3 to 5 times per week. More participants in the Modius Stress arm achieved a 4 point or more reduction in GAD-7 score from baseline to the follow-up visit compared with the sham group (97% [33 out of 34] vs 24% [6 out of 25], respectively). The Modius Stress group had a reduction of 7.44 in GAD-7 score vs a reduction of 2.23 in the sham group (mean difference, -5.21 [95 CI, -6.57, -3.85]; P <.0001).

“GAD affects an estimated 6.8 million adults in the US, over 3% of the population, with women twice as likely to be affected as men, according to the American Depression and Anxiety Association,” said Dr Jason McKeown, CEO of Neurovalens. “Modius Stress is a noninvasive device that treats the underlying issue to improve the lives of patients.”

The investigational therapy combines MDMA, a psychoactive drug, with psychological interventions that include psychotherapy, talk therapy and other supportive services. The NDA is supported by 2 randomized, double-blind, placebo-controlled phase 3 studies: MAPP1 (ClinicalTrials.gov Identifier: NCT03537014) and MAPP2 (ClinicalTrials.gov Identifier: NCT04077437). 

Findings from both studies showed treatment with MDMA-assisted therapy significantly reduced PTSD symptoms compared with placebo as measured by the change from baseline in the Clinician-Administered PTSD Scale for DSM-5 score (primary endpoint). Moreover, significant improvement in functional impairment associated with PTSD (measured by the change from baseline in the Sheehan Disability Scale total score) was observed with MDMA vs placebo.

“Securing Priority Review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD,” said Amy Emerson, CEO of Lykos Therapeutics (formerly MAPS Public Benefit Corporation). “We remain focused on working with the FDA through the review process and preparing for a controlled launch with an emphasis on quality should this potential treatment be approved.”

A Prescription Drug User Act target date of August 11, 2024 has been set for the application.