US biotech Cephalon said yesterday its recently-approved analgesic Fentora could have applications in the treatment of lower back pain, based on the results of a Phase III trial.
Fentora (fentanyl), a novel painkiller that is dosed orally and delivers active drug via an effervescent lozenge that is held inside the cheek, was approved towards the end of September in the USA to treat chronic pain in patients with cancer.
Cephalon said in a statement that the results from the clinical trial showed that Fentora had a statistically significant effect in relieving lower back pain within 10 minutes of dosing, compared with placebo, and was also better at all subsequent timepoints tested out to 120 minutes.
The data will be presented in more detail at the American Society of Regional Anesthesia and Pain Medicine conference, which starts on November 16 in San Francisco.
News of the new potential indication for Fentora is important for Cephalon, which us positioning the product as a successor to its Actiq (fentanyl), a lollipop formulation that accounted for a third of the company’s $1.2 billion in sales last year.
Actiq is facing generic competition in the USA from Barr Pharmaceuticals, which launched its version of the product at the end of September. Cephalon and Barr cut a deal earlier this year to keep the generic off the market until Fentora won approval, and Cephalon now manufactures fentanyl citrate for Barr while the Food and Drug Administration reviews the latter’s own marketing application for the drug.
Fentora is priced at a discount to branded Actiq, and this should help accelerate take-up of the new product, according to analysts at JMP Securities.
An estimated 51% of people with chronic pain report back pain, making it the most common chronic pain condition, according to the American Chronic Pain Association.