Contributions
Abstract: EP1564
Type: ePoster
Abstract Category: Therapy - symptomatic - Treatment of specific symptoms
Objective: To evaluate the safety and tolerability of AERT over 1 year of treatment and the long-term effects on spasticity.
Background: Spasticity is common in MS and is associated with significant morbidity. The standard treatment is oral administration of baclofen, a γ-aminobutyric acid-b (GABA-b) receptor agonist. Baclofen is a racemic mixture and its biological activity is thought to be due to the R-enantiomer (arbaclofen). Therapeutic doses of baclofen can cause CNS side effects that may affect adherence and tolerability. AERT can reduce dosing frequency and adverse events.
Design/Methods: This was a multicenter, open label, single arm study that enrolled patients with spasticity due to MS. All subjects received AERT and were maintained on the highest tolerated dose up to 20 mg bid for up to a year. AERT was gradually withdrawn at the end of the maintenance period. The study assessed safety parameters and the severity of spasticity using Total Numeric-transformed Modified Ashworth Scale (TNmAS).
Results: The study enrolled 184 subjects, 63[percnt] were female, mean age was 48 years, average duration of MS diagnosis was 12 years, and mean baseline TNmAS score of 6.29. The most common adverse events (AEs) reported were muscle weakness (13[percnt]), somnolence (9.80[percnt]), dizziness (8.7[percnt]), incontinence (fecal 7.1[percnt], urinary 6.5[percnt]), urgency (7.1[percnt]), pollakiuria (6.5[percnt]), asthenia (6[percnt]), and nausea (6[percnt]). AEs led to study discontinuation in 9.8[percnt] of subjects. No effects on laboratory parameters, vital signs, or ECGs were observed. TNmAS score decreased during the up-titration period, and remained consistent during the maintenance period. The improvement in spasticity was greater in subjects receiving 30 & 40 mg/day compared to 20 mg/day.
Conclusions: AERT administered twice a day was safe and well tolerated in MS patients with spasticity. A reduction in spasticity, measured by TNmAS, was maintained throughout the treatment period.
Disclosure: Study supported by Osmotica Pharmaceutical.
Dr. Hunter has received research support from Genzyme/Sanofi. Dr. Kantor has received personal compensation for activities with Avanir, Genzyme, Biogen Idec, Novartis, Questcor, Teva, Depomed, Osmotica, and Allergan. Dr. Dentiste has received personal compensation for activities with Osmotica as an employee. Dr. Aikman has received personal compensation for activities with Osmotica as an employee. Dr. Kaba has received personal compensation for activities with Osmotica Pharmaceutical as an employee.
Abstract: EP1564
Type: ePoster
Abstract Category: Therapy - symptomatic - Treatment of specific symptoms
Objective: To evaluate the safety and tolerability of AERT over 1 year of treatment and the long-term effects on spasticity.
Background: Spasticity is common in MS and is associated with significant morbidity. The standard treatment is oral administration of baclofen, a γ-aminobutyric acid-b (GABA-b) receptor agonist. Baclofen is a racemic mixture and its biological activity is thought to be due to the R-enantiomer (arbaclofen). Therapeutic doses of baclofen can cause CNS side effects that may affect adherence and tolerability. AERT can reduce dosing frequency and adverse events.
Design/Methods: This was a multicenter, open label, single arm study that enrolled patients with spasticity due to MS. All subjects received AERT and were maintained on the highest tolerated dose up to 20 mg bid for up to a year. AERT was gradually withdrawn at the end of the maintenance period. The study assessed safety parameters and the severity of spasticity using Total Numeric-transformed Modified Ashworth Scale (TNmAS).
Results: The study enrolled 184 subjects, 63[percnt] were female, mean age was 48 years, average duration of MS diagnosis was 12 years, and mean baseline TNmAS score of 6.29. The most common adverse events (AEs) reported were muscle weakness (13[percnt]), somnolence (9.80[percnt]), dizziness (8.7[percnt]), incontinence (fecal 7.1[percnt], urinary 6.5[percnt]), urgency (7.1[percnt]), pollakiuria (6.5[percnt]), asthenia (6[percnt]), and nausea (6[percnt]). AEs led to study discontinuation in 9.8[percnt] of subjects. No effects on laboratory parameters, vital signs, or ECGs were observed. TNmAS score decreased during the up-titration period, and remained consistent during the maintenance period. The improvement in spasticity was greater in subjects receiving 30 & 40 mg/day compared to 20 mg/day.
Conclusions: AERT administered twice a day was safe and well tolerated in MS patients with spasticity. A reduction in spasticity, measured by TNmAS, was maintained throughout the treatment period.
Disclosure: Study supported by Osmotica Pharmaceutical.
Dr. Hunter has received research support from Genzyme/Sanofi. Dr. Kantor has received personal compensation for activities with Avanir, Genzyme, Biogen Idec, Novartis, Questcor, Teva, Depomed, Osmotica, and Allergan. Dr. Dentiste has received personal compensation for activities with Osmotica as an employee. Dr. Aikman has received personal compensation for activities with Osmotica as an employee. Dr. Kaba has received personal compensation for activities with Osmotica Pharmaceutical as an employee.