Thanks to Buccolam, the reality of suppressing convulsive seizures in children and adolescents approaches parents' ideal management

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In acute therapy of convulsive seizures accompanying status epilepticus in children and adolescents, benzodiazepines are currently recommended. Apart from their anticonvulsant effect, they also act as sedatives, anxiolytics, and muscle relaxants. In the form of diazepam, they are available for intravenous and per rectum administration.

An alternative to diazepam is a buccal midazolam solution – Buccolam. According to current medical evidence, its efficacy, safety, and tolerance are comparable to diazepam. Additionally, it has been available on the market for 12 years, and over 2 million doses were administered in more than 20 countries worldwide in 2022, reflecting numerous positive practical experiences. 

Effective and Safe

Buccolam is as effective as diazepam in stopping seizures. McIntyre et al. published a study comparing the efficacy and safety of the drug with rectally administered diazepam, which even demonstrated significantly higher efficacy (56% vs. 27%).

The major safety risk when using benzodiazepines is respiratory depression. Its incidence in the case of buccal midazolam solution, according to Anderson's review, is 0.6–5%, which is similar to diazepam therapy. Some parents might worry about the risk of aspiration when applying the drug in the mouth. However, these are theoretical concerns that have not been confirmed in reality. The volume of saliva produced during a seizure far exceeds the amount of the administered drug.

Unmatched Onset Speed When Applied in the Patient's Natural Environment

Buccolam is applied between the cheek and gums. The buccal mucosa is an ideal site for medication administration for several reasons: it has a relatively large and well-vascularized surface, and the absorbed medication directly enters systemic circulation. Due to lower enzyme expression and activity in the mouth, the drug degradation is lower compared to other parts of the gastrointestinal tract. Unlike other orally administered drugs, the first-pass effect through the liver does not pose an issue.

How does this therapy fare in terms of onset speed? The effect of Buccolam begins within 10 minutes, with the average time to seizure cessation being 8 minutes. Although this is longer than intravenous diazepam, when preparation time is included, Buccolam is favorable. Compared to rectally administered diazepam, Buccolam's onset is quicker (e.g. Moretti et al.).

Main Benefits − Simplicity and Social Acceptability of Administration

As Buccolam is indicated for the treatment of prolonged convulsive seizures in infants, toddlers, children, and adolescents aged 3 months to 18 years − except for the youngest group under 6 months, where the medication must be administered in a hospital setting with life-function monitoring and resuscitation equipment available − the usual administrators are parents or other lay caregivers. For them, the simplicity of administration is crucial. 

This is confirmed by a parental survey evaluating satisfaction with Buccolam administration, the results of which were published by Khan et al. According to the vast majority of parents (91%), the therapy was always or mostly effective in ending convulsive seizures. Parents who had experience with rectally administered diazepam preferred Buccolam − not only due to less sedation but also due to its more acceptable administration method.

Buccolam is available in doses of 2.5 mg, 5 mg, 7.5 mg, and 10 mg, with different color-coded variants for various age categories, while the concentration of midazolam in solution remains 5 mg/ml. Each package contains the medication prepared for immediate use in prefilled applicators. These rounded syringes, which pose a very low risk of accidental injury, resemble children's syrup dispensers, so parents can easily use them to apply the medication by gently pressing the plunger between the gum and the inner cheek. The dose can be split in half to each side of the cheek. Parents can easily learn the procedure from a short instructional video.

If the seizure does not end within 10 minutes of administering the medication, it is necessary to call emergency medical services and hand over the empty applicator directly to the paramedics.

Parents prefer Buccolam not only for its simple administration but also because it protects the patient's privacy during use. Moreover, choosing Buccolam does not require compromising on treatment efficacy, safety, or onset speed. All these factors contribute to making the reality align closer to parents' ideal vision of managing their children's convulsive seizures.

(pok)

Sources:
1. SPC Buccolam. Available at: www.ema.europa.eu/en/documents/product-information/buccolam-epar-product-information_cs.pdf
2. 12 years of jointly caring for epilepsy patients. Letter to physicians. Neuraxpharm, Prague, 2023.
3. Anderson M. Buccal midazolam for pediatric convulsive seizures: efficacy, safety, and patient acceptability. Patient Prefer Adherence 2013; 7: 27–34, doi: 10.2147/PPA.S39233.
4. McIntyre J., Robertson S., Norris E. et al. Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial. Lancet 2005; 366 (9481): 205–210, doi: 10.1016/S0140-6736(05)66909-7.
5. Moretti R., Julliand S., Rinaldi V. E., Titomanlio L. Buccal midazolam compared with rectal diazepam reduces seizure duration in children in the outpatient setting. Pediatr Emerg Care 2019; 35 (11): 760–764, doi: 10.1097/PEC.0000000000001114.
6. Khan A., Baheerathan A., Setty G., Hussain N. Carers' express positive views on the acceptability, efficacy, and safety of buccal midazolam for paediatric status epilepticus. Acta Paediatr 2014; 103 (4): e165–e168, doi: 10.1111/apa.12529.