Swedish biotech company AlzeCure Pharma AB (Nasdaq First North Premier Growth Market:ALZCUR) reported on Tuesday that the European Medicines Agency (EMA) has granted orphan drug designation to ACD440 for treatment of erythromelalgia, a rare chronic pain disorder with no approved therapies.

ACD440, the company's lead pain candidate within the Painless platform, previously completed a positive Phase IIa study in chronic peripheral neuropathic pain and received US orphan designation and FDA positive guidance in 2025 supporting continued Phase II/III development toward regulatory approval.

ACD440 is a first-in-class TRPV1 antagonist being developed as a topical gel to deliver high local analgesic effect with minimal systemic exposure. The compound originated in large pharmaceutical research and is based on Nobel Prize-recognised science from 2021.

Erythromelalgia affects just over 13 per 100,000 people and is characterised by severe burning pain, redness, swelling, and heat, primarily in the extremities such as the feet, hands, ears and nose.