Takeda narcolepsy pill approved by DEA for US sale
Takeda announced that its narcolepsy medication Orzeyful is now available in the United States after the Drug Enforcement Administration removed the final regulatory hurdle.
US approval and pricing details
According to the DEA, Orzeyful is categorized as a Schedule IV controlled substance that presents a low risk of abuse. Every strength of the product carries a U.S. list price of $16,500 for each 60-tablet bottle. This marks the first treatment to target the underlying cause of this rare sleep disorder. Approximately 120,000 people in the United States currently have the condition requiring this specific therapy.
Pfizer discontinues Premarin supply
After an internal review, Pfizer decided to stop selling the hormone replacement therapy Premarin in Canada. Previously, the product existed as a vaginal cream alongside three strengths of oral tablets. Premarin vaginal cream used to treat menopause symptoms has faced shortage since June with no further batches supplied. Prescriptions for hormone replacement therapy have grown especially in the United States following the removal of safety warnings.
Supply constraints continue elsewhere
Currently, Canada is experiencing supply shortages for various other hormone treatments used to manage menopause symptoms as well. The FDA removed long-standing safety warnings a year ago which led to increased prescriptions for these medications. Reuters notes the specific details regarding the DEA classification and the pricing structure for the new drug.
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