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Important Safety Information Full Prescribing Information

About DIACOMIT®

Proven efficacy in pivotal studies

With DIACOMIT®, patients experienced significantly fewer seizures versus placebo1

STICLO France: 71% of the DIACOMIT® patients responded to treatment, versus 5% in the placebo group1‑3

STICLO Italy: Comparable results were observed, with a response rate of 67% for DIACOMIT® versus 9% in the placebo group1‑3

Primary endpoint: response to DIACOMIT®1,2,*

STICLO POOLED RESULTS (N=64)

43% and 25% of patients in STICLO France and STICLO Italy, respectively, reported no generalized clonic or tonic-clonic seizures for the entirety of the study1,2

Additional endpoint: seizure-free patients1,4,†

STICLO POOLED ADDITIONAL ENDPOINTS (N=64)

Patient characteristics in both studies1:

  • Children 3 to <18 years of age
  • Confirmed diagnosis of Dravet syndrome
  • Inadequately controlled on clobazam and valproate
  • Suffering from ≥4 generalized clonic or tonic-clonic seizures per month, despite optimized therapy

Primary endpoint: responder rate1,*

Secondary endpoint: mean change from baseline in frequency of generalized clonic or tonic-clonic seizures1

DIACOMIT® is the first antiepileptic drug to have clinically demonstrated its efficacy in Dravet syndrome in 2 multicenter, double-blind, placebo-controlled, randomized trials: STICLO France (Lancet, 2000) and STICLO Italy (Epilepsia, 2008§).1‑3,5,6

Both studies were conducted according to the same protocol. The Italian study was performed after the French study and provided comparable results.1,2

Study Design: The efficacy of DIACOMIT® was established in 2 multicenter, placebo-controlled, double-blind, randomized studies conducted according to similar protocols. Patients and/or caregivers recorded the frequency of generalized clonic or tonic‑clonic seizures during the study period.1

The objective of these pivotal studies was to confirm the efficacy of DIACOMIT® in Dravet syndrome patients with pharmacoresistant seizures in spite of clobazam and valproate treatments.1

*Response was defined as experiencing a ≥50% decrease in the frequency of generalized clonic or tonic‑clonic seizures during the treatment period compared with baseline.3,6
Seizure freedom was defined as experiencing no generalized clonic or tonic-clonic seizures for the duration of the study.1,2
The effectiveness of DIACOMIT® for the treatment of seizures associated with Dravet syndrome in patients 2 years of age to less than 3 years of age was extrapolated from the demonstration of effectiveness in patients 3 years to less than 18 years of age in STICLO France and STICLO Italy. Safety and effectiveness in pediatric patients below the age of 2 years have not been established.1,2
§Systematic review and meta-analysis. Trial results from STICLO Italy were not directly published.6
CI, confidence interval.
References:

1. DIACOMIT® (stiripentol) prescribing information. Beauvais, France: BIOCODEX; 2018. 2. US Food and Drug Administration. Center for Drug Evaluation and Research Clinical Review: DIACOMIT, stiripentol. August 2018. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/206709Orig1s000,207223Orig1s000MedR.pdf. Accessed March 12, 2019. 3. Chiron C, Marchand MC, Tran A, et al; and the STICLO study group. Stiripentol in severe myoclonic epilepsy in infancy: a randomised placebo-controlled syndrome-dedicated trial. Lancet. 2000;356(9242):1638-1642. 4. Chiron C. Stiripentol. Expert Opin Investig Drugs. 2005;14(7):905-911. 5. Brigo F, Igwe SC, Bragazzi NL. Antiepileptic drugs for the treatment of infants with severe myoclonic epilepsy. Cochrane Database Syst Rev. 2017;5:CD010483. doi:10.1002/14651858.CD010483.pub4. 6. Kassaï B, Chiron C, Augier S, et al. Severe myoclonic epilepsy in infancy: a systematic review and meta-analysis of individual patient data. Epilepsia. 2008;49(2):343-348.

IMPORTANT SAFETY INFORMATION AND INDICATION
INDICATION

DIACOMIT (stiripentol) capsules for oral use or powder for oral suspension are indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam.

There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

No contraindications are listed.

WARNINGS & PRECAUTIONS
Somnolence

DIACOMIT can cause somnolence. Monitor patients for somnolence, particularly when DIACOMIT is used concomitantly with other CNS depressants or clobazam, which is also known to cause somnolence.

Decreased Appetite and Decreased Weight

DIACOMIT can cause decreases in appetite and weight. The growth and weight of pediatric patients treated with DIACOMIT should be carefully monitored.

Neutropenia and Thrombocytopenia

DIACOMIT can cause significant declines in neutrophil and platelet counts. Hematologic testing should be obtained prior to starting treatment with DIACOMIT and then every 6 months.

Withdrawal Symptoms

As with most antiepileptic drugs (AEDs), DIACOMIT should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus.

Risks in Patients with Phenylketonuria (PKU)

DIACOMIT powder for suspension contains phenylalanine, which can be harmful to patients with PKU. Before prescribing DIACOMIT powder for suspension to a patient with PKU, consider the total daily intake of phenylalanine from all sources, including DIACOMIT powder for suspension. DIACOMIT capsules do not contain phenylalanine.

Suicidal Behavior and Ideation

AEDs, including DIACOMIT, increase the risk of suicidal thoughts or behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

ADVERSE REACTIONS

The most common adverse reactions that occurred in at least 10% of DIACOMIT-treated patients and more frequently than on placebo were somnolence, decreased appetite, agitation, ataxia, decreased weight, hypotonia, nausea, tremor, dysarthria, and insomnia.

PREGNANCY

There are no adequate data on the developmental risks associated with the use of DIACOMIT in pregnant women. Based on animal data, DIACOMIT may cause fetal harm.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as DIACOMIT, during pregnancy. Physicians are advised to recommend that pregnant patients taking DIACOMIT enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry (information at http://www.aedpregnancyregistry.org). This can be done by calling the toll free number 1‑888‑233‑23341‑888‑233‑2334, and must be done by patients themselves or their caregiver.

To report suspected adverse reactions, contact BIOCODEX at 1‑866‑330‑30501‑866‑330‑3050 or FDA at 1‑800‑FDA‑10881‑800‑FDA‑1088 or www.fda.gov/medwatch

Please see full prescribing information for DIACOMIT®.