Buccolam (midazolam oromucosal solution) / Takeda - LARVOL DELTA

A Survey of Midazolam in People With Status Epilepticus (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: Takeda | Trial completion date: May 2026 ➔ May 2027 | Trial primary completion date: May 2025 ➔ May 2027

Trial completion date • Trial primary completion date • CNS Disorders • Epilepsy

Perpetrator DDI Potential of Givinostat as Inhibitor and Inducer of CYP3A and P-gp Activity (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: Italfarmaco | N=54 ➔ 26

Enrollment change

VOLUNTARY ANNOUNCEMENT SIHUAN PHARMACEUTICAL’S PRODUCT MIDAZOLAM OROMUCOSAL SOLUTION INCLUDED IN THE NATIONAL DRUG REIMBURSEMENT LIST 2022 (iis.aastocks.com) - "The board of directors (the 'Board') of Sihuan Pharmaceutical Holdings Group Ltd...is pleased to announce that, according to the 'Notice on the Publication of the National Drug Reimbursement List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2022 Version)' (the 'NDRL 2022') officially issued by the National Healthcare Security Administration and the Ministry of Human Resources and Social Security of the People’s Republic of China (the 'PRC'), midazolam oromucosal solution (the 'Product') produced by the Group’s subsidiary, Jilin Sihuan Aokang Pharmaceutical Co., Ltd., is included in the NDRL 2022."

Reimbursement • CNS Disorders • Epilepsy

Neuraxpharm completes its presence in Benelux by opening an affiliate in Brussels to cover Belgium and Luxembourg (PRNewswire) - "Neuraxpharm Group...announces the establishment of Neuraxpharm Belgium to cover Belgium and Luxembourg, completing its presence in Benelux as it continues its expansion pathway in Europe....Neuraxpharm Belgium will be based in Brussels and will distribute and market prescription brand Buccolam® (midazolam), which is indicated for the emergency treatment of children and adolescents with epileptic seizures..."

Clinical • CNS Disorders • Epilepsy

AOTMiT recommends: a drug used in epilepsy for reimbursement [Google translation] (Rynekzdrowia) - "The drug recommended for reimbursement contains the substance Midazolam and is classified as a benzodiazepine...the President of the Agency for Health Technology Assessment and Tariffication issued the following recommendation on reimbursement of medicinal products in the indication: treatment of prolonged acute seizures in infants, young children, children and adolescents (from 3 months to 18 years). Buccolam, Midazolamum, Oral solution, 2.5 mg / 0.5 ml, 4 amps. 0.5 ml, GTIN code: 05909991449568; Buccolam, Midazolamum, Oral solution, 5 mg / ml, 4 amps. 1 ml, GTIN code: 05909991449575; Buccolam, Midazolamum, Oral solution, 7.5 mg / 1.5 ml, 4 amps. 1.5 ml, GTIN code: 05909991449582; Buccolam, Midazolamum, Oral solution, 10 mg / 2 ml, 4 amps. 2 ml, GTIN code: 05909991449599."

Reimbursement • CNS Disorders • Epilepsy

A Survey of Midazolam in People With Status Epilepticus (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: Takeda

New trial • CNS Disorders • Epilepsy

AOTMiT Transparency Council, incl. about the drug for breast cancer [Google translation] (Polityka Zdrowotna) - "Preparation of drug assessment positions: Buccolam (midazolamum) in the indication: treatment of prolonged acute seizures in infants, toddlers, children and adolescents (from 3 months to 18 years)."

Reimbursement • CNS Disorders • Epilepsy

AOTMiT: What will the Transparency Council do in March? (Google translation) (medexpress.pl) - "MEETING OF THE COUNCIL FOR TRANSPARENCY NO. 11/2022 MARCH 14, 2022...Buccolam (midazolamum) - CONDITIONAL Indication: as part of the drug program: 'Treatment of prolonged, acute seizures in infants, toddlers, children and adolescents (from 3 months to 18 years)' Decision problem: preparing a position on drug evaluation."

Reimbursement • CNS Disorders • Epilepsy

A Phase 3 open-label study of the efficacy, safety and pharmacokinetics of buccally administered midazolam hydrochloride for the treatment of status epilepticus in pediatric Japanese subjects. (PubMed, Epilepsy Res) - "The efficacy, safety and pharmacokinetic profile of MHOS in pediatric Japanese subjects was consistent with that observed in non-Japanese populations. Compared to IV treatments, MHOS offers easier administration which may reduce the time to treatment and thereby minimize the sequelae of prolonged seizures."

Clinical • Journal • P3 data • PK/PD data • CNS Disorders • Depression • Epilepsy • Pediatrics • Psychiatry

Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety (clinicaltrials.gov) - P4; N=150; Recruiting; Sponsor: Universitair Ziekenhuis Brussel; Trial completion date: Aug 2020 ➔ Feb 2022; Trial primary completion date: Aug 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Aesthetic Medicine • Anesthesia • Mood Disorders • Otorhinolaryngology • Pediatrics • Psychiatry

Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting (clinicaltrials.gov) - P3; N=3; Completed; Sponsor: Shire; Recruiting ➔ Completed

Clinical • Trial completion • Epilepsy • Pediatrics

Neuraxpharm launches first product in Japan (PRNewswire) - "Neuraxpharm...today announces the launch in Japan of the recently acquired prescription brand Buccolam® (oromucosal midazolam) following its approval as the first buccally administered formulation for the treatment of status epilepticus (SE) in the country...Takeda launches the product and remains the marketing authorization holder of Buccolam in Japan for a transitional phase."

Launch Japan • CNS Disorders • Epilepsy

Seizure management and prescription patterns of anticonvulsants in Dravet syndrome: A multicenter cohort study from Germany and review of literature. (PubMed, Epilepsy Behav) - "This is the first comprehensive report of routine AEDs and emergency medication use in a large sample of patients with DS in Germany over a period of 3-6 months and shows that despite the most common AED combinations being in line with clinical guidelines/best practice, there is no discernable impact of best treatment on seizure frequency. We find a higher use of bromide in Germany compared with other real-world evidence in Europe."

Clinical • Journal • CNS Disorders • Epilepsy

Midazolam oral transmucosal route. An alternative to rectal diazepam for some children. (Prescrire Int) - PMID: 23951591; "In practice, rectal diazepam is the drug of choice for paediatric convulsive seizures occurring outside the hospital setting. Midazolam oromucosal solution is an alternative for children over 6 months of age, especially when preparation or administration of the rectal diazepam dose poses a problem."

Review • Epilepsy

Shire to present at the Cowen and Company 34th Annual Health Care Conference (PRNewswire) - “Shire's Chief Executive Officer… will present at the Cowen and Company 34th Annual Health Care Conference today, March 4th at 08:00 AM EST/13:00 GMT.”

Anticipated conference • Epilepsy

Buccolam: The first centralized paediatric use marketing authorization (Int J Pharm) - Abstract not available

Regulatory • Epilepsy

"#Industria España retira 24 lotes de #Buccolam de @Shireplc por una alerta europea de la @EMA_News https://t.co/k9he9yuiol" (@redaccionmedica)

Biosimilar

Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting (clinicaltrials.gov) - P3; N=6; Recruiting; Sponsor: Shire; Trial completion date: Nov 2019 ➔ Dec 2020; Trial primary completion date: Nov 2019 ➔ Dec 2020

Trial completion date • Trial primary completion date

Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan (clinicaltrials.gov) - P3; N=25; Completed; Sponsor: Shire; Recruiting ➔ Completed; Trial completion date: Nov 2019 ➔ Aug 2019; Trial primary completion date: Nov 2019 ➔ Aug 2019

Clinical • Trial completion • Trial completion date • Trial primary completion date

Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety (clinicaltrials.gov) - P4; N=150; Recruiting; Sponsor: Universitair Ziekenhuis Brussel

Clinical • New P4 trial

Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children with Status Epilepticus (Convulsive) in a Healthcare Setting in Japan (clinicaltrialsregister.eu) - P3; N=25; Sponsor: Shire

Clinical • New P3 trial

The effect of tablet-multimedia versus midazolam medication on the level of preoperative anxiety in pediatric day-care. (clinicaltrialsregister.eu) - P4; N=150; Sponsor: Universitair Ziekenhuis Brussel (UZ Brussel)

Clinical • New P4 trial

Buccal Midazolam Solution for the Management of Prolonged Acute Convulsive Seizures: A Cost Analysis. (PubMed, Pharmacoecon Open) - "The availability of single-unit Epistatus allows for greater flexibility in prescribing. Physicians should attempt to categorise patients according to past PACS frequency with low PACS patients being prescribed single unit Epistatus (with/without spare loading) and 4-pack Buccolam reserved for patients in whom a high volume of usage is anticipated."

HEOR • Journal

Drug Interaction Study With RV521 in Healthy Volunteer Subjects (clinicaltrials.gov) - P1; N=82; Completed; Sponsor: ReViral Ltd; Recruiting ➔ Completed

Trial completion