August in Review: Updates on the Psychiatric Treatment Pipeline

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Take a look at this month’s developments in the psychiatric treatment pipeline. We compiled a recap of the latest news here, just in case you missed any of the updates.

End of Phase 2 Meeting With the FDA: Adial Prepares to Advance AD04 for Alcohol Use Disorder

Adial Pharmaceuticals announced the completion of a successful end of phase 2 meeting with the US Food and Drug Administration (FDA), in which the FDA provided input into the AD04 phase 3 adaptive design clinical trial and the overall clinical program. AD04 is Adial’s lead investigational treatment, a genetically targeted selective serotonin-3 receptor (5-HT3) antagonist and therapeutic agent for the treatment of alcohol use disorder (AUD) in patients who engage in heavy drinking (defined as < 8 drinks/drinking day).

Investigational Prescription Digital Therapeutic CT-155 for Negative Symptoms of Schizophrenia Meets Primary Study End Point

Boehringer Ingelheim and Click Therapeutics announced that the pivotal phase 3 CONVOKE study of CT-155 (BI 3972080), an investigational prescription digital therapeutic (PDT), met its primary end point. Investigators compared the effectiveness and safety of CT-155 vs a digital control app as an adjunct to standard of care antipsychotic therapy in individuals with symptoms of schizophrenia and found that CT-155 showed a reduction in experiential negative symptoms.

FDA Grants Type C Meeting for Aversa Fentanyl Abuse Deterrent Patch

The FDA has granted a Type C Meeting for Nutriband’s lead product, Aversa fentanyl, or the abuse deterrent fentanyl transdermal system. In the meeting, the FDA will specifically provide feedback on the chemistry, manufacturing, and controls plans for Aversa fentanyl from the submission of an Investigational New Drug Application through approval of a 505(b)(2) New Drug Application and subsequent commercialization. Aversa technology combines Nutriband's abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch to improve safety. Accidental exposure to fentanyl patches, especially in children, is a significant concern, and Aversa technology aims to mitigate this risk.

FDA Grants Fast Track Designation for NRX-100 for Suicidal Ideation in Patients With Depression, Including Bipolar Depression

NRx Pharmaceuticals announced that the FDA has granted Fast Track designation to NRX-100 for the treatment of suicidal ideation in patients with depression, including bipolar depression. NRX-100 is the first preservative-free formulation of intravenous ketamine for acute suicidal crises in depression. Currently available forms of ketamine contain the preservative benzethonium chloride, but its safety for repeated use has never been demonstrated. The FDA's decision aligns with the Commissioner's National Priority Voucher Program and Accelerated Approval Program, recognizing NRX-100's potential to meet unmet medical needs.

FDA Approves KETARx for Management of Surgical Pain

The FDA has approved PharmaTher Holdings’ ketamine product, KETARx, for its indicated uses in surgical pain management. Ketamine has potential in mental health and neurological disorders, despite regulatory challenges and supply shortages. Addressing pain management with ketamine could improve mental health outcomes and quality of life for patients. The approval follows 2 complete response letters addressing minor deficiencies without requiring new trials.

FDA Approves Tonmya, First Fibromyalgia Medication in 15 Years

The FDA has approved Tonix Pharmaceuticals' Tonmya (cyclobenzaprine HCl, formerly known as TNX-102 SL), a novel treatment form for fibromyalgia. The drug is now the first in a new category of nonopioid analgesics for fibromyalgia and the first new medication for this disorder in 15 years. Sublingual administration of Tonmya allows for faster action and reduced adverse effects by avoiding first-pass hepatic metabolism. Tonmya is also being explored for other conditions, including PTSD and Alzheimer disease agitation, with expected availability by late 2025.

BXCL501 for Agitation Associated With Bipolar Disorders or Schizophrenia: Positive Pre-sNDA Meeting With FDA

BioXcel Therapeutics announced that it has received positive pre supplemental New Drug Application (sNDA) meeting responses from the FDA on its candidate BXCL501 for agitation associated with bipolar disorders or schizophrenia. Outside of the FDA-approved indication, dexmedetomidine (Igalmi) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, which is a selective alpha-2 adrenergic receptor agonist. The primary purpose of the planned meeting with FDA was to gain alignment on the content and format of the planned submission for the outpatient use of BXCL501. This includes the clinical, nonclinical, and chemistry and manufacturing and controls requirements.

FDA Grants Fast Track Designation to Pemvidutide for Treatment of Alcohol Use Disorder

Altimmune announced that the FDA has granted Fast Track designation to pemvidutide for the treatment of alcohol use disorder. Pemvidutide is a novel, investigational, peptide-based 1:1 GLP-1/glucagon dual receptor agonist. The phase 2 trial RECLAIM (NCT06987513) evaluating the safety and efficacy of pemvidutide in alcohol use disorder is currently enrolling. Investigators anticipate needing approximately 100 participants, who will be randomly assigned 1:1 to receive either 2.4 mg pemvidutide or placebo once weekly for 24 weeks. The primary endpoint of the trial is the change from baseline in the average number of heavy drinking days.

Leqembi for Alzheimer Disease Launches in First European Union Countries

Eisai and Biogen recently announced that the anti-amyloid beta (Aβ) monoclonal antibody lecanemab-irmb (Leqembi) for the treatment of Alzheimer disease has been launched in Austria on August 25, 2025, and will be launched in Germany on September 1, 2025. Leqembi received approval from the European Commission in April 2025 as the first therapy that targets an underlying cause of Alzheimer disease. Germany and Austria will mark the first launches in the EU.

Positive Phase 2 Results: Psilocybin-Assisted Psychotherapy Treatment, PSX-001, for Generalized Anxiety Disorder

Incannex Healthcare shared positive data from its phase 2 clinical trial of PSX-001 (formerly known as Psi-GAD), a psilocybin-assisted psychotherapy treatment for generalized anxiety disorder. Participants treated with PSX-001 achieved statistically significant and clinically meaningful improvements across every key endpoint assessed in the study, reinforcing its potential as a treatment for patients with moderate to severe generalized anxiety disorder.

Primary Endpoint of Phase 3 Trial Met: BXCL501 for Agitation Associated With Bipolar Disorders or Schizophrenia

BioXcel Therapeutics today announced that the SERENITY At-Home pivotal phase 3 trial evaluating the safety of BXCL501, an acute treatment for agitation associated with bipolar disorders or schizophrenia in the at-home setting, met its primary endpoint: being well tolerated during treatment of agitation episodes in patients with bipolar disorders or schizophrenia in the at-home setting. BXCL501's success supports an sNDA for label expansion, addressing unmet needs in at-home agitation management and potentially reducing health care costs.

New Expanded Access Policy for NRX-100 for Suicidal Ideation

NRx Pharmaceuticals announced expanded access for NRX-100, a preservative free intravenous ketamine, in treating suicidal ideation in patients with depression following the Fast Track designation by the FDA. NRX-100 is available upon physician request for patients meeting the expanded access criteria.

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