Cephalon reports positive data for Fentora painkiller

Cephalon, the American pharmaceutical company, has published new data from a phase III trial to study the efficacy of Fentora in treating chronic lower back pain.

Researchers observed a statistically significant difference in pain intensity within ten minutes of treatment, as well as at all subsequent time points in a 120-minute period. Additionally, adverse effects were found to be of a similar nature to other opioid drugs.

The drug already has approval in the US to treat breakthrough pain in cancer patients and this latest study could mean the drug can be used for other indications, according to the company.

Dr Lesley Russell, senior vice president of worldwide medical and regulatory operations, commented: “In opioid-tolerant patients, we believe Fentora has the potential to address the rapid onset characteristic of breakthrough pain, a common component of low back pain.”

She added that the study results “provide important support” to Cephalon’s strategy of expanding Fentora’s label to include indications for breakthrough pain associated with “multiple” chronic pain diseases.

In August, Cephalon announced it had ceased developing Sparlon, an investigational treatment for attention deficit-hyperactivity disorder. The American regulator failed to approve the drug after one case of Stevens-Johnson syndrome apparently developed in a patient taking Sparlon.

Despite new data submitted by the company, which concluded that the case was not Stevens-Johnson syndrome, the FDA decided against approval. Frank Baldino Jr, chairman and chief executive officer at Cephalon, said the company was “extremely disappointed and surprised” at the ruling.