August 03, 2022
2 min learn
Tariot PN., et al. Bioequivalence and security comparability of once-weekly donepezil transdermal system with oral donepezil: outcomes of a part 1 pharmacokinetic research in wholesome volunteers. Introduced at: Alzheimer’s Affiliation Worldwide Convention; July 31-Aug. 4; San Diego.
Disclosures: Tariot is employed by Banner Alzheimer’s Institute. Oh is employed by Corium Inc.
SAN DIEGO — A once-weekly dose of transdermal donepezil proved a secure and efficient equal to a each day dose of oral donepezil for Alzheimer’s-related dementia, per a presenter on the Alzheimer’s Affiliation Worldwide Convention.
“Donepezil, a reversible acetylcholinesterase inhibitor, is essentially the most prescribed remedy for the remedy of dementia of the Alzheimer’s kind in sufferers with gentle, reasonable and extreme illness,” Pierre N. Tariot, of Banner Alzheimer’s Institute in Phoenix, famous in his poster presentation.
Tariot and fellow researchers sought to look at the bioequivalence in addition to the security and efficacy of transdermal donepezil (Adlarity, Corium) dosage as soon as per week in contrast with a once-daily oral dosage in a cohort of wholesome adults.
The researchers performed an open-label, randomized, crossover, three-period trial with 60 volunteer members aged 18 to 55 years. All members obtained 5 mg per day of transdermal donepezil throughout the 5-week interval 1, adopted by 10 mg per day of transdermal donepezil or 10 mg per day of oral donepezil within the 5-week interval 2; remedies had been switched in interval 3. Bioequivalence was assessed at regular state in week 5 of every remedy. Security and tolerability had been additionally evaluated.
Outcomes confirmed that, at regular state, adjusted geometric imply ratios (aGMR; % [90% CI]) of transdermal donepezil to oral donepezil for optimum plasma focus and space beneath the plasma focus versus time curve (0 to 168 hours) had been 88.7 (81.7 to 96.2) and 108.6 (100.5 to 117.4) for 10 mg per day and 86.1 (79.8 to 92.9) and 105.3 (97.6 to 113.6) for five mg per day of transdermal donepezil. The 90% CIs for the GMRs had been usually inside the accepted 80% to 125% vary for establishing bioequivalence. Antagonistic occasions had been reported in 80% of members: 53.3% for the 5 mg per dday transdermal donepezil, 54.5% for the ten mg per day transdermal donepezil and 57.1% for oral donepezil.
Information moreover revealed that, aside from stomach ache (5.5% vs 1.8%), fewer gastrointestinal adverse events had been reported with 10 mg per day of transdermal than oral donepezil (constipation, 5.5% vs. 17.9%; nausea 1.8% vs. 30.4%; diarrhea 3.6% vs. 12.5%), respectively. There have been additionally fewer adversarial occasions of dizziness (3.6% vs. 19.6%) and no incidence of somnolence (0 vs. 10.7%) reported with transdermal. No severe adversarial occasions, or these resulting in remedy discontinuation or loss of life had been reported.
“Examine outcomes demonstrated that handy once-weekly Adlarity affords vital potential profit to sufferers and caregivers as a result of it’s equal to an oral tablet taken each day however affords a decrease danger of troublesome GI unwanted side effects,” Charles Oh, MD, chief medical officer of Corium, stated in a launch that accompanied the research.
- Corium’s new once-weekly transdermal Alzheimer’s dementia remedy Adlarity (donepezil transdermal system) offers drug supply equal to oral donepezil with favorable GI aspect impact profile. Printed Aug. 1, 2022. Accessed Aug. 3, 2022.