Pharma giant Johnson & Johnson JNJ announced Monday it had asked the Food and Drug Administration (FDA) to approve its nasal spray as a monotherapy for treatment-resistant depression (TRD) in adults.
The New Jersey-based company's Spravato, contains esketamine as an active ingredient, which is a nasal spray derivative formulation of a dissociative anesthetic, ketamine. While for years, ketamine has been used as an anesthetic in medical settings, recent clinical trials led to its broader application, most commonly for depression treatment.
FDA approved Spravato in 2019 but only in combination with oral antidepressants; it is available through a restricted program requiring monitoring by healthcare professionals. If the FDA approves the new drug application, this will be the first and only monotherapy for adults with treatment-resistant depression, writes Green Market Report's Adam Jackson.
Nearly 30% of the estimated 280 million people worldwide living with major depressive disorder have TRD, which occurs when there is an inadequate response to two or more oral antidepressants during the same depressive episode.
More Than A Decade Of Research
“Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones,” stated Bill Martin, the head J&J's neuroscience team. “We’re pleased to build on the more than a decade of research reinforcing the safety and efficacy of SPRAVATO and look forward to working with the FDA to bring this innovative treatment to patients as a monotherapy option.”
The application is supported by positive results from a Phase 4 study that showed Spravato, when used alone, produced "a rapid change in Montgomery-Asberg Depression Rating Scale total score as early as 24 hours after the first Spravato dose and sustained through at least 4 weeks of treatment," J&J said.
To date, Spravato has been approved in 77 countries and administered to more than 100,000 people worldwide.
Strong Sales
J&J recently reported its financial results revealing nearly 100% growth in Spravato sales year-over-year. While the company suppressed analyst forecasts by reporting adjusted earnings per share of $2.80 versus the consensus of $2.62 and raised full-year earnings guidance, Spravato's sales numbers stood out, wrote Shadd Dales for Benzinga.
In the U.S. and worldwide, year-over-year Spravato revenues grew 93.2% and 98.5%, respectively. Overall, Spravato’s growth was by far the strongest in Johnson & Johnson's Neuroscience portfolio, easily topping CONCERTA (Methylphenidate) growth on a worldwide basis (28.6%).
Price Action
J&J's shares traded 1.32 lower at $152.27 per share during Monday's mid-day session.
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