Dive Brief:
- Compounding kit maker CutisPharma Inc. will try its hand at selling an oral liquid formulation of the antibiotic vancomycin, securing U.S. approval of the drug for treatment of Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus.
- Called Firvanq, CutisPharma's version will be launched in April 2018 and will replace the company's vancomycin compounding kit, which allowed pharmacists to make liquid formulations of the drug for patients unable to take the drug by other means.
- C diff-associated diarrhea affects over half a million patients in the U.S. every year, according to the company. Firvanq is the only FDA-approved vancomycin oral liquid treatment option.
Dive Insight:
The process of compounding allows pharmacists or physicians to create bespoke medications for patients, such as liquid formulations of drugs only available as pills. Compounding can be time-consuming though, and has its own risks from contamination.
CutisPharma's business is built around its compounding kits, which are designed to produce easy-to-swallow liquids for individuals unable to swallow tablets or capsules. The company's aim is to offer a standardized alternative to traditional compounding methods. (It's worth noting that CutisPharma's kits are not subject to FDA approval, although the company says it sources kit components from FDA-approved and GMP-complaint facilities).
The company shifted its focus toward developing drugs for FDA approval several years ago, inking an API collaboration agreement with Dr Reddy's Laboratories Ltd. in 2016. While details on the private company's pipeline are scant, CutisPharma say it's pushing four candidates through clinical development.
Given the company's focus on making compounding kits of older, available medicines, a natural niche could center on developing new formulations of those drugs for FDA approval.
CutisPharma hopes approval of Firvanq will encourage payer reimbursement of the drug — an issue with its compounding kits.
A 2012 outbreak of fungal meningitis caused by drugs compounded by the New England Compounding Center (NECC) triggered increased scrutiny of industry practices. Contaminated drugs compounded by NECC led to over 750 cases of illness and more than 60 deaths.
Prompted by the tragedy, Congress passed the Drug Quality and Security Act in November 2013 to tighten oversight of the sector. More recently, the FDA announced a new plan aimed at "reinvigorating" efforts to improve production standards for compounded drug products.