On Friday, Cumberland Pharmaceuticals Inc. said that the U.S. regulator has decided to exceed the review date of Acetadote drug, which is used in the treatment of patients who suffer from non-acetaminophen acute liver failure.

The review period has been extended for three months by FDA, and the final decision will be taken in December. After this news, the Company’s share rolled down 10.3% to $5.40 in after-hours trading period.

Acetadote medicine can be used in place of acetaminophen, which causes liver damage when taken in large quantity.

It is worth mentioning that almost half of acute liver failure cases are caused by taking over dosage of painkiller, acetaminophen.

Other causes of liver failure are hepatitis B, autoimmune hepatitis Wilson disease, fatty liver of pregnancy, and haemolysis, elevated liver enzymes, low platelets (HELLP) syndrome.

Acute liver failure has a high mortality rate and requires regular liver transplantation.

At present, liver transplantation is the only treatment available for those patients who have a damaged liver not caused by acetaminophen poisoning.

Cumberland is seeking approval from FDA to use Acetadote drug in patients with non-acetaminophen acute liver failure.

Mr. A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals, said, “We look forward to continued discussion with the FDA regarding this potentially life-saving treatment for patients who have few alternatives”.