FDA Approves New Liquid Formulation of Evoxac
The oral solution offers a new way to manage dry mouth symptoms for patients living with Sjögren's disease.
Updated on Oct. 20, 2026 in Diabetes
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The FDA has officially approved a liquid formulation of Evoxac to help patients with Sjögren's disease manage dry mouth symptoms. This new version provides an alternative treatment option for those who struggle with swallowing traditional capsules.
Why it matters
While the drug addresses specific symptoms, there are currently no FDA-approved therapies that treat the underlying autoimmune cause of Sjögren's disease. The liquid formulation improves accessibility for patients with difficulty swallowing.
Cosette Pharmaceuticals secured approval using the 505(b)(2) pathway, which leverages existing safety and efficacy data from the legacy capsule formulation. This bypasses the need for a full-scale clinical development program.
The players
Cosette Pharmaceuticals
This New Jersey-based company is a specialty pharmaceutical firm focused on developing and commercializing medications for various therapeutic categories.
Daiichi Sankyo
This is a global pharmaceutical company headquartered in Japan that previously marketed Evoxac in capsule form.
FDA
The Food and Drug Administration is the federal agency responsible for protecting public health by ensuring the safety and efficacy of medical products in the United States.
The details
Cosette Pharmaceuticals acquired the rights to Evoxac from Daiichi Sankyo in 2022 and utilized the 505(b)(2) NDA pathway to gain approval for the new liquid version. The medication is specifically designed to manage dry mouth, a common symptom for individuals diagnosed with the autoimmune disorder.
Timeline
Cosette Pharmaceuticals acquired Evoxac from Daiichi Sankyo in 2022.
The FDA approved the liquid formulation of Evoxac in October 2026.
Cosette Pharmaceuticals expects the new oral solution to launch by the end of 2026.
Health Landscape
The approval of this liquid formulation reflects a broader trend in the pharmaceutical industry to improve patient adherence by repurposing established compounds through the FDA's 505(b)(2) pathway. This strategy allows companies to address unmet needs in administration without the lengthy timelines of traditional drug discovery.
This approval provides a more accessible option for patients who experience difficulty swallowing, which is a common hurdle with existing capsule treatments. Patients should consult their healthcare provider to discuss whether this new formulation is appropriate for their specific care plan once it becomes available.
The takeaway
The development of a liquid option demonstrates how pharmaceutical companies can utilize regulatory pathways to improve the usability of existing treatments for chronic conditions. Patients should keep an eye on upcoming pharmacy availability as the manufacturer prepares for the year-end rollout.
What happens next
Cosette Pharmaceuticals plans to initiate the U.S. market launch of the liquid Evoxac formulation by the end of 2026.
Further reading
Learn more about evolving treatment options for chronic conditions in the United States Diabetes section.
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