CEP 33237 filed at FDA for treatment for chronic pain-Teva
Teva Pharmaceutical Industries Ltd., announced that the FDA has accepted for review the New Drug Application (NDA) for the company�s hydrocodone bitartrate extended-release (ER) tablets formulated with Teva�s proprietary abuse deterrence technology (CEP-33237). CEP-33237 is an investigational, 12-hour, acetaminophen-free, formulation of extended-release hydrocodone for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Comment:The nasal HAL study found that in non-dependent, recreational opioid users, abuse potential for crushed intranasal CEP-33237 was significantly lower than intranasal immediate-release (IR) hydrocodone.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.