The positive ADHD data for Otsuka Pharmaceutical’s centanafadine is good news in what has of late been a mixed bag for the neuropsychiatric space.
Otsuka Pharmaceuticals’ investigational treatment for attention-deficit/hyperactivity disorder significantly reduced overall symptoms and feelings of anxiety in a Phase 3b study, beefing up the company’s case for the drug as an FDA decision looms.
At eight weeks, patients on Otsuka’s candidate, dubbed centanafadine, showed a 5.87-point improvement over placebo in ADHD symptom burden, as measured by a semi-structured interview tool. This effect was statistically significant, the company said in a Thursday release.
Moreover, Otsuka noted that statistical separation between centanafadine and placebo started as early as the first week and persisted through the rest of the follow-up period.
Centanafadine also significantly lowered anxiety symptoms, as measured by a separate scale, with a 1.92-point advantage in patients receiving the investigational drug. Otsuka said centanafadine also met other secondary outcomes, though it did not elaborate further. The company plans to present a more detailed analysis of the study at an upcoming scientific conference.
Designed to be taken orally, centanafadine is a triple reuptake inhibitor, preventing the reabsorption of norepinephrine, dopamine and serotonin into cells after they transmit a neuronal message. That way, these neurotransmitters stay in the synapse and continue signaling for longer than they would otherwise.
The drug is currently under FDA review for ADHD, with a target action date of July 24. Data from Thursday’s readout were not part of Otsuka’s regulatory submission.
Thursday’s positive data for centanafadine add to biopharma’s recent clinical and regulatory wins across the neuropsychiatric space. In February, the FDA signed off on Vanda Pharmaceuticals’ Bysanti for first-line treatment of schizophrenia and manic or mixed episodes in patients with bipolar I disorder.
Then, last week, an independent study found that the dopamine agonist pramipexole could help patients with mood disorders feel pleasure—an outcome that Jefferies said in a May 15 note “instills confidence” in Alto Neuroscience’s ALTO-207 for treatment-resistant depression. ALTO-207 is a fixed-dose combination of pramipexole with antiemetic ondansetron. The drug is in mid-stage development, with data expected later this year.
But not all has gone smoothly for the neuropsych field. In April, Newron Pharmaceuticals disclosed a patient death in a late-stage study of its oral glutamate modulator evenamide for treatment-resistant schizophrenia, prompting the FDA to put the trial under a clinical hold. Earlier this month, Neumora Therapeutics decided to scrap its oral drug candidate navacaprant after disappointing results in two Phase 3 studies.
