What to Know About ZTALMY

For caregivers of people with CDKL5 deficiency disorder

What is ZTALMY?

ZTALMY is a prescription medicine used to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder in people 2 years of age and older. It is not known if ZTALMY is safe and effective in children under 2 years of age. ZTALMY is a sugar-free cherry-flavored oral suspension suitable for ketogenic diets.

What is CDKL5 deficiency disorder?

CDKL5 deficiency disorder, or CDD, is a rare genetic disorder characterized by treatment-resistant seizures that start in infancy and significant developmental delays.

What does FDA approval mean?

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research has reviewed data on ZTALMY and has decided that the benefits outweigh the risks for the treatment of seizures associated with CDD in people 2 years of age and older.

When will ZTALMY be available?

ZTALMY is expected to be available in July 2022.

Why is there a delay between FDA approval and prescription availability?

The FDA has recommended that ZTALMY be classified as a controlled substance. This recommendation has been submitted to the US Drug Enforcement Administration (DEA). ZTALMY will be available following controlled substance scheduling by the DEA.

What is a controlled substance?

Any newly developed medicine that has a possibility for abuse or dependence is classified as a controlled substance and is scheduled by the DEA. Schedule I (one) drugs have the highest potential for abuse, and Schedule V (five) drugs have a lower potential for abuse. Like some other seizure medicines, ZTALMY is a controlled substance.

How can I stay informed about ZTALMY?

Ask your child’s healthcare team about ZTALMY at your next appointment. Your healthcare team can help you stay informed about when ZTALMY will be available.