In clinical trials, a total of 578 patients received selegiline medication ODT. The most common adverse drug events reported, compared with placebo, were dizziness, nausea, pain, headache, insomnia, rhinitis, dyskinesia, back pain, stomatitis, and dyspepsia. Side effects that prompted discontinuation of therapy included dizziness, chest pain, accidental injury, and myasthenia.
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In an open-label extension study, Lew et al. evaluated the long-term safety, efficacy, and tolerability of adjunctive selegi-line ODT 2.5 mg in patients who completed either of two large phase 3 double-blind studies. The study had been scheduled to end after 12 months, but it was amended to be open-ended.
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A 12-week, multicenter, randomized, placebo-controlled trial was conducted to evaluate the safety and efficacy of selegiline tablet ODT as adjunctive therapy in patients with PD. A total of 140 patients were assigned to two treatment arms; 94 patients received selegiline ODT, and 46 patients received placebo.
Selegiline HCl is a levo-rotatory acetyl-enic derivative of phenthylamine. It is chemically designated as (-)-(R)-N, a-dimethyl-N-2-propynylphenethyl-amine HCl. Its empirical formula is C13H17N • HCl, and its molecular weight is 223.75. Figure 1 illustrates the agent’s chemical structure.
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Historically, target populations for new fast-dissolving or quick-disintegrating formulations have been geriatric, bedridden, developmentally disabled and pe-diatric patients. In addition, patients with limited access to water, such as travelers, and patients with persistent nausea are also suitable candidates for this practical technology. Several products already utilize Zydis technology and are presented in Table 1.
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INTRODUCTION Parkinson’s disease (PD) is a chronic, progressive neurodegenerative disorder characterized by four cardinal features: tremor at rest, rigidity, bradykinesia, and postural instability. PD results from a loss of dopaminergic neurons in the substantia nigra pars compacta. Approximately one million Americans currently have PD, and an estimated 40,000 new cases are diagnosed each year. In [...]
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