Breakthrough Cancer Pain Drug New Formulation

Breakthrough Cancer Pain Drug New Formulation

Breakthrough cancer pain is a large and often undertreated problem.

As one provider, who wished not to the identified, told the National Pain Report.”Often because we are focused on killing the cancer, we sometimes can under treat the pain.”

More companies are working on the treatment of breakthrough cancer pain. One of them, BioDelivery Sciences International, Inc. (NASDAQ: BDSI) has  announced the FDA has approved a Supplemental New Drug Application (sNDA) for a new formulation of the company’s ONSOLIS® product for the management of breakthrough pain in patients with cancer who are opioid tolerant.

Most people treated for moderate to severe persistent pain experience breakthrough pain, with an average of 4 episodes per day. Breakthrough pain flares may be caused by disease, treatment, or other unrelated factors.

Episodes are often unpredictable, brought on by something as simple as swallowing or coughing (“spontaneous” pain). People may also experience breakthrough pain flares as they reach the end of their dose of persistent pain medication.

While breakthrough pain flares may vary in length, intensity, or cause, the typical episode reaches peak intensity in as little as 3 minutes and lasts an average of 30 minutes.

Breakthrough pain is different from persistent pain and requires different treatment. The ideal treatment for breakthrough pain is a strong, short-acting opioid medication that works quickly and lasts about as long as a breakthrough pain episode. Breakthrough pain medication is taken on an as-needed basis, as soon as symptoms are experienced. Breakthrough pain treatment is prescribed in addition to long-acting medication (usually an opioid) taken around-the-clock to maintain control over persistent pain.

BDSI also announced that it taking over the marketing of ONSOLIS from its partner Meda Pharmaceuticals.

“We are pleased to have obtained FDA approval of our sNDA and to now be in a position to move toward returning ONSOLIS to the U.S. marketplace,” said Dr. Mark A. Sirgo, President and Chief Executive Officer.  “ONSOLIS remains an important differentiated fentanyl containing product for this indication given that it is the only product for buccal administration, providing patients with an alternative dosing option.”

According to information provided by the Company, “Up to 86 percent of Americans suffering from cancer-related and other types of chronic pain experience breakthrough pain episodes, even when their persistent pain is well-managed.”

 

Authored by: Ed Coghlan