Teva to seek FDA approval for abuse-resistant hydrocodone

Teva Pharmaceutical Industries has announced its intention to submit a rolling new drug application (NDA) to the US Food and Drug Administration for its new hydrocodone bitartrate drug.

CEP-33237 is an investigational acetaminophen-free formulation of extended-release hydrocodone and is intended for use in the management of pain so severe it requires daily, long-term treatment with opioids.

The company intends to complete the NDA submission by the end of the year, seeking to utilise the FDA's fast-track programme for the drug, which has potential abuse-deterrent properties.

Michael Hayden, president of global research and development and chief scientific officer at Teva, said: "Teva understands the risk of opioid abuse is a societal challenge and one many healthcare professionals face in treating people living with chronic pain."

HAL studies of the two most common routes of hydrocodone abuse – oral and intranasal – have demonstrated abuse potential for CEP-33237 is significantly lower than intranasal IR hydrocodone powder.

In addition, phase III trials showed the drug was effective in producing large improvement in the treatment of patients with chronic lower back pain, as measured by both the weekly average worst pain intensity and weekly average pain intensity scores.