After several rejections over 20-plus years, Fabre-Kramer Pharmaceuticals has secured the FDA’s approval for its major depressive disorder drug gepirone hydrochloride, now marketed under the brand name Exxua.
Pictured: Woman sits alone with her head in her hands/iStock, simpson33
The FDA on Thursday approved Fabre-Kramer Pharmaceuticals’ extended-release gepirone hydrochloride tablets, to be marketed under the brand name Exxua, for the treatment of major depressive disorder in adults.
The privately-held company contends that Exxua is the “first and only approved” antidepressant for the treatment of major depressive disorder (MDD) in adults that works through the selective agonism of 5HT1a receptors, modulating serotonin activity throughout the central nervous system. The drug’s mechanism of action has yet to be fully elucidated.
Exxua’s label bears a boxed warning for suicidal thoughts and behaviors in children and young adults, for which the drug is not approved for use. In its announcement on Thursday, however, Fabre-Kramer pointed out that the oral drug does not come with safety precautions for sexual dysfunction and weight gain. The company expects to launch Exxua in early 2024.
CEO Stephen Kramer called Exxua’s approval an “important milestone in the treatment of MDD,” adding that the drug can provide patients and physicians with “a new option” to manage depression and improve quality of life.
To support Exxua’s novel activity, Fabre-Kramer backed its regulatory application with data from over 5,000 patients, which showed that the antidepressant could effectively ease depressive symptoms “with an acceptable side effect profile,” according to the company. The most common adverse events were dizziness and nausea, which were mostly mild and transient.
Sexual side effects and weight gain, common problems associated with antidepressants, were not more common among Exxua-treated patients than in placebo comparators.
Thursday’s approval is the culmination of Fabre-Kramer’s decades-long regulatory journey for the MDD drug. The company filed the first New Drug Application for gepirone hydrochloride in September 1999 and was subsequently rejected by the FDA in 2002.
The antidepressant drug has since encountered several regulatory roadblocks in the years since, including a Psychopharmacologic Drugs Advisory Committee meeting in 2015 that ended in a 9-4 vote against Fabre-Kramer, according to a report from MDedge at the time. The external experts found that the company had not provided enough evidence to support the drug’s efficacy.
In a press release posted following the advisory committee meeting, however, Fabre-Kramer focused on the panel’s 11-2 vote supporting gepirone’s safety, noting that the experts “expressed overwhelming support” for the candidate’s safety.
With the MDD approval finally secured, Fabre-Kramer will now work to bring Exxua to other indications. The company is developing the drug as a treatment for other psychiatric disorders.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
