Intermezzo Finally Gains FDA Approval
Transcept Pharmaceuticals has finally secured the approval of regulators in the USA for their insomnia medication, Intermezzo.
The US Food and Drug Administration (FDA) have approved Intermezzo (zolpidem) to treat insomnia characterised by middle-of-the-night waking followed by difficulty returning to sleep, which is a form of insomnia that is estimated to affect millions of adults in the United States. This is the first time the FDA has approved a drug for this condition.
The treatment is a low dosage of zolpidem, the active ingredient in Sanofi’s sleeping pill Ambien, which was first approved in 1992 in the USA. The advised and maximum dose of Intermezzo is 3.5 mg for men and 1.75mg for women and the elderly (over 65s), as women clear zolpidem from the body at a slower rate.
Intermezzo is formulated as a sublingual tablet that contains a bicarbonate-carbonate buffer and is intended to be positioned under the tongue where it is allowed to disintegrate entirely prior to swallowing.
The announcement is a major boost for Transcept, who received an additional complete response letter from the FDA in July, (the original rejection came in October 2009). The agency at the time said that the study conducted to evaluate the effect of Intermezzo on subjects’ next-day driving ability was not sufficient to grant approval.
Transcept duly re-filed the drug at the end of September and reduced the recommended Intermezzo dose for women to 1.75mg. Their proposal also contained instructions stating that the drug should only be taken if patients have a minimum of four hours of bedtime remaining, and they should not drive for at least an hour after arising and until four hours after taking the sublingual tablet.
Robert Temple, deputy centre director for clinical science in the FDA’s Center for Drug Evaluation and Research, commented that “with this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving.” The FDA also noted that Intermezzo is a federally controlled substance because it can be abused or lead to dependence.
Intermezzo was studied in two trials, involving over 370 patients. The trials showed that those taking the drug had shorter time to fall back to sleep after waking, compared to people on placebo. The most frequently reported adverse reactions were headaches, nausea and fatigue.
Transcept has agreed to post-marketing commitments including a study of patient compliance and paediatric use assessment. Intermezzo will be sold by their partner, Purdue Pharma. Under the agreement, Purdue has until 8th December 2011 to notify Transcept whether it will proceed with the commercialisation of Intermezzo.