SRX246 is an investigational medication being developed by Azevan Pharmaceuticals to treat neuropsychiatric conditions.

Now in the clinical testing stage, it is being investigated as a possible treatment for intermittent explosive disorder, which is characterized by sudden aggressive outbursts, and post-traumatic stress disorder (PTSD), which is triggered by a terrifying event and results in anxiety, nightmares, and flashbacks. In a Phase 1/2 clinical trial (NCT02055638), SRX246 was shown to be well-tolerated and of clinical benefit to adults with intermittent explosive disorder.

SRX246 is also being assessed to possibly treat irritability in Huntington’s disease patients. Huntington’s often leads to irritable and aggressive behavior in affected individuals, substantially impacting their daily life.

How SRX246 works

SRX246 interferes with the action of vasopressin, a signaling molecule in the brain. Vasopressin binds to the so-called vasopressin 1a receptors. The mechanism by which vasopressin influences mood is not entirely understood, but high brain levels of vasopressin are associated with aggressive and irritable behavior. By binding to vasopressin 1a receptors, SRX246 blocks vasopressin’s action.

SRX246 in clinical trials

A Phase 1/2 double-blind and placebo-controlled clinical trial (NCT02507284) may still enrolling Huntington’s disease patients with evidence of irritability to assess the tolerability, safety, and activity of oral SRX246 over 12 weeks of treatment.  A total of 108 patients will be enrolled at 22 sites across the U.S.; more information is available here.

Trial participants are being divided into three groups. Two groups will receive different doses of SRX246, with the third being given a placebo. During the baseline phase, patients in both SRX246 groups will receive 80 mg of SRX246 for two weeks (given as a divided dose, twice daily). The dose will then escalate to 120 mg — divided, twice daily — for four weeks. One group will then continue with a total 120 mg of SRX246 twice daily for the trial’s remaining six weeks, while the other will move to 160 mg, divided and twice daily, for those final weeks.

Additional information

SRX246 is reported to be well-tolerated, and no serious adverse events found in a clinical trial dosing up to 160 mg twice daily. Adverse events were reported to be mild, transient, and not dose-dependent.

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