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# HedgePath Orphan Status for Basal Cell Carcinoma Drug
- URL: https://www.fdaweb.com/hedgepath-orphan-status-for-basal-cell-carcinoma-drug/
- Published: 2016-06-03T12:00:00.000Z
- Updated: 2026-09-14T21:07:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135830

FDA has granted HedgePath Pharmaceuticals an orphan drug designation for SUBA-itraconazole capsules for treating patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS) with its oral formulation of SUBA-Itraconazole capsules. BCCNS results from a genetic mutation that causes the Hedgehog pathway to function improperly, leading to the chronic formation of basal cell tumors, including potentially disfiguring lesions on the face. The company says its current Phase 2(b) trial has shown evidence of substantial clinical benefit in subjects currently enrolled, and it will seek further discussions with FDA as to whether the results from this trial could potentially serve as the basis for an NDA.

HedgePath says that SUBA-itraconazole is a proprietary itraconazole formulation that enhances the absorption of itraconazole to improve the bioavailability of orally administered drugs that are poorly soluble. “SUBA-itraconazole was developed to improve absorption and significantly reduce variability compared to generic itraconazole,” it says. “These benefits provide enhancements to patients and prescribers with reduced intra- and inter-patient variability, enabling a more predictable clinical response and a reduction in the active drug quantity to deliver the required therapeutic blood levels.”