Cephalon, Inc. (Nasdaq: CEPH) announced that it has received an approvable letter, together with draft labeling, from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for NUVIGIL(TM) (armodafinil) Tablets [C-IV] for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift work sleep disorder (SWSD).
The draft labeling includes a proposed bolded warning section that characterizes the potential occurrence of skin rash and hypersensitivity in patients taking modafinil and armodafinil. As expected, the agency also has indicated that it will request similar language in the label for PROVIGIL(R) (modafinil) Tablets [C-IV]. The proposed labeling is subject to final approval by the FDA.
“We have worked diligently with the FDA over the past six months on this issue, and they have now informed us that their review is complete. We are very pleased that the proposed warning language appropriately describes the product’s safety profile,” said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations.
Among other things, the agency has requested that the company provide a standard safety update from clinical trials conducted since the last update in June 2006, and introductory promotional materials to be used for the product. The company’s response will be submitted within 30 days and will be considered a Class I response; the agency is expected to complete its review within 60 days thereafter. The agency has not requested any additional studies prior to final approval of NUVIGIL.
“While we fully appreciate that this regulatory review has been difficult and lengthy for stockholders and others interested in the outcome, we are convinced that in this unusual situation where multiple products may be affected, the final result will prove to be worth the investment of time and effort,” said Frank Baldino Jr., Ph.D., Chairman and CEO of Cephalon.
NUVIGIL is a single-isomer formulation of modafinil, the active pharmaceutical ingredient contained in PROVIGIL which is FDA-approved for the treatment of excessive sleepiness associated with narcolepsy, OSAHS and SWSD. The NUVIGIL NDA is based on positive results of four double-blind, randomized, placebo-controlled studies in patients with excessive sleepiness associated with either narcolepsy, SWSD or OSAHS. In these studies, NUVIGIL was generally well tolerated. The most common side effects were mild to moderate in intensity and included nausea, headaches, dizziness, diarrhea, decreased appetite and upset stomach.