FDA clears liver cyrossis drug for Phase II study: 4 notes

The Nashville-based pharmaceutical company Cumberland Pharmaceuticals has received FDA clearance for a randomized, placebo-controlled Phase II clinical study. The study will investigate Portaban, a treatment Cumberland Pharmaceuticals developed for liver cyrossis patients.

Here's what you need to know:

1. Portaban is an oral drug made with ifetroban, which was shown to reduce portal pressure, necrosis, inflammation and fibrosis in liver injury during preclinical studies.

2. The researchers will study whether Portaban can lower elevated portal pressures in patients with portal hypertension, a complication of liver cyrossis.

3. The researchers believe the drug will decrease risk of hepatic decompensation and may even improve long-term liver function.

4. Portaban is Cumberland Pharmaceuticals' fourth development candidate. Its other products include treatments for hepatorenal syndrome, respiratory disease and systemic sclerosis.

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