February in Review: Updates on the Psychiatric Treatment Pipeline

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This month, there were a few important developments in the psychiatric treatment pipeline. We compiled a recap of the latest news here, just in case you missed any of the updates.

Targeting the Brain: A New Path Forward for IBS Treatment

A new study shows that opioid delta-receptor (DOP) agonists target the central nervous system, potentially alleviating irritable bowel syndrome (IBS) symptoms linked to psychological stress. A novel animal model demonstrated that DOP agonists regulate glutamate neurotransmission in the insular cortex, improving IBS symptoms. This suggests that DOP agonists may offer a more definitive IBS treatment with minimal adverse effects compared with current therapeutic options.

CYB003 for the Adjunctive Treatment of Major Depressive Disorder

CYB003, a deuterated psilocybin molecule, is being evaluated for major depressive disorder (MDD) in the PARADIGM phase 3 program, aiming for a paradigm shift in depression treatment. The program includes 3 pivotal studies: APPROACH, EMBRACE, and EXTEND, targeting patients with moderate to severe MDD who inadequately respond to current antidepressants. In current phase 2 trials, participants showed significant symptom improvement and high remission rates with CYB003. This supports the phase 3 design's focus on durable, intermittent treatment. Additionally, CYB003 was well tolerated with no serious adverse events, indicating a favorable safety profile for potential future use in MDD treatment.

Patent Issued for Methods of Identifying Patients With Substance Use-Associated Genetic Markers, Treatment With AD04

The United States Patent and Trademark Office issued patent number 12,221,654 for Adial Pharmaceuticals’ identification of patients with specific genetic markers linked to substance use disorders and treatment with AD04. AD04 targets patients with the TT genotype of rs1042173 in the serotonin transporter gene, addressing opioid and alcohol use disorders. Pharmacokinetics research supports AD04's micro-dosing regimen, showing proportional ondansetron exposure and administration flexibility with or without food.

SPN-820 Fails to Meet Primary Endpoint in Study of Adults with Treatment-Resistant Depression

SPN-820 did not achieve significant improvement in treatment-resistant depression in a phase 2b study, failing its primary endpoint of change from baseline. The study examined the efficacy and safety of SPN-820 over a course of 4 weeks of treatment and then a week of blinded placebo-washout in approximately 250 patients from approximately 40 clinical sites. The primary outcome measure was the change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score to week 4; SPN-820 did not achieve statistically significant improvement (SPN-820 [LS mean ± Standard Error]: -12.3 ± 0.96 vs placebo: -11.9 ± 0.96; P = not significant). There was no treatment difference between SPN-820 and placebo in the change from baseline to week 4 for the secondary endpoints.

FDA Approves of Label Changes for Sublocade Injection for Opioid Use Disorder

The US Food and Drug Administration (FDA) approved of key modifications to the administration protocol for injectable long-acting opioid use disorder treatment buprenorphine (Sublocade). These key modifications include a rapid treatment initiation protocol and expanded alternative injection site options. Expanded injection site options for Sublocade include abdomen, thigh, buttock, and back of the upper arm, enhancing treatment flexibility. These changes aim to improve patient adherence and outcomes, aligning treatment with real-world clinical needs.

Positive FDA Feedback for Proposed In Vitro Bridging Strategy for Alcohol Use Disorder Treatment, AD04

The FDA gave positive feedback to Adial Pharmaceuticals regarding its proposed in vitro bridging strategy for the phase 3 formulation of AD04, an investigational selective serotonin-3 receptor (5-HT3) antagonist. The FDA agreed with Adial’s proposed 505(b)(2) bridging strategy of leveraging the results from the relative bioavailability food-effect study, AD04-103, along with in vitro dissolution data demonstrating equivalence between the comparison product and the planned commercial formulation of AD04. Even though the final determination will depend on a comprehensive review of the complete New Drug Application, the FDA’s agreement represents a significant regulatory milestone for Adial. After securing this regulatory confirmation, Adial will proceed with manufacturing clinical supply materials in preparation for the upcoming phase 2 clinical program in 2025.

FDA Officially Removes REMS Requirement for Clozapine

The FDA announced it will eliminate the risk evaluation and mitigation strategies (REMS) program for clozapine and does not expect prescribers, pharmacies, and patients to report results of absolute neutrophil count (ANC) blood tests before pharmacies dispense clozapine. Despite removing REMS, the FDA still advises monitoring ANC levels, maintaining safety warnings in prescribing information. This decision is expected to decrease health care burdens and improve clozapine access, with manufacturers updating prescribing information accordingly.

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