FDA stalls the approval of Cephalon’s Nuvigil Jet Lag drug
By Yugo on Mar 30, 2010 in Health News, United States
In a recent development, Cephalon’s sleep disorder drug Nuvigil has been declined for approval by U.S health regulators. The move comes after questioning the quality of some of some of the data used in the making of the drug. This has also resulted in a sharp decline of the drug maker’s shares by 5 percent.
The medicine, Nuvigil, a follow up to Cephalon’s flagship sleep disorder drug Provigil was introduced in June for excessive fatigue caused by narcolepsy, shift work and sleep apnea. The company was seeking to expand the drug’s label to include approval to treat jet lag resulting from eastbound travel.
However, instead of a final decision from the U.S Food and Drug Administration (FDA), Cephalon received a response letter of denial to approve the drug for jet lag this time. It’s certainly not the largest new indication for Nuvigil, but it was obviously the nearest-term shot on goal,” said Holley, who is based in New York. It may be interesting to note that he is among 17 analysts who recommend buying Cephalon shares, of the 25 analysts surveyed by Bloomberg. Offering Nuvigil for jet lag may add $150 million to the company’s annual sales, he noted.
Travelers who cross three or more time zones in a trip are the most likely to suffer jet lag. According to the Centers for Disease Control and Prevention Agency in U.S, Jet Lag is a condition marked by a disrupted sleep cycle, headaches, or an upset stomach. Initially, The FDA had given an expedited six month evaluation for jet lag as part of a priority review program for novel medicines. However, the agency delayed its decision by three months in December as it required time to consider the submission. It was also noticed that, on a normal range , people on the drug took an average of 11.7 minutes to fall asleep compared to 4.8 minutes for people on the placebo pill.
