Eton Pharmaceuticals launches Impavido capsules in the U.S.

Eton Pharmaceuticals (Nasdaq: ETON) announced the commercial launch of Impavido (miltefosine) capsules in the United States, with the company holding exclusive commercialization rights for the drug.

Impavido is an antileishmanial drug indicated for adults and adolescents 12 years of age and older weighing at least 30 kg for the treatment of visceral, cutaneous, and mucosal leishmaniasis caused by specific Leishmania species.

Distribution is centralized through Anovo Specialty Pharmacy, which is intended to support outpatient prescribing, inpatient consignment, and urgent access coordination. Clinicians can e-prescribe by selecting Anovo #5 (Memphis) or submit a patient referral form by fax.

Eton has also integrated its Eton Cares patient support program, which includes a $0 co-pay option for eligible commercially insured patients and expanded patient assistance programs.

"By bringing Impavido into Eton's rare disease commercial infrastructure, we can pair this important therapy with high-touch services designed to help support healthcare providers and expand access for patients," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

The company said it is also working to expand hospital on-site availability through a consignment inventory stocking program. For urgent patient needs, Anovo will coordinate an emergency access pathway involving clinicians, CDC representatives, and hospital pharmacies.

The drug carries a boxed warning for embryo-fetal toxicity and is contraindicated in pregnancy. Common adverse reactions include nausea, vomiting, diarrhea, headache, and elevated liver transaminases.

Eton currently markets eleven rare disease products and has five additional product candidates in late-stage development.

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