Summary: Twenty-three narcoleptic subjects participated in a single-blind drug study with placebo-viloxazine hydrochloride (100 mg/day). One woman discontinued the study because of nausea and headaches during the treatment period. The remaining 22 subjects were polygraphically monitored during baseline, placebo intake, viloxazine treatment, and placebo intake following 48 h of drug withdrawal. Symptoms and side effects were evaluated subjectively and objectively. Except for the subject who discontinued the study, viloxazine was well tolerated, particularly in elderly subjects. The drug had an inhibitory effect on REM sleep, cataplexy, and other auxiliary symptoms. While there is no objective evidence that it heightens alertness, patients reported fewer sleep attacks. Key Words: Narcolepsy-Viloxazine hydrochloride.As reported by International Chemicals, Inc., the viloxazine molecule is derived from propranolol (lnderal), a cardiovascular drug with significant l3-adrenoceptor blocking properties. Experiments have shown that viloxazine hydrochloride has a significant, and probably specific, noradrenergic reuptake blocking property. On the other hand, viloxazine does not appear to have anticholinergic properties. In Europe it has been widely and satisfactorily used as an antidepressant drug but has not been tested systematically in narcoleptic subjects. R. Clark (personal communication, 1983) in Columbus, Ohio, in an open, nonsystematic trial, found that some narcoleptic patients reported subjective symptomatic improvements with this drug. A systematic multicenter study was then planned, the preliminary results of which are presented here.
As the voice of cancer care clinicians and the patients they serve, ASCO has taken steps to elevate awareness about biosimilar products and their use in oncology. In 2018, ASCO released its Statement on Biosimilars in Oncology which was subsequently published in the Journal of Clinical Oncology to serve as an educational tool which highlighted and provided guidance on several topical areas surrounding biosimilars. At the time of its publication, the US Food and Drug Administration (FDA) had approved eight biosimilar products for use in the United States, including one product for use as a supportive care agent in the cancer setting and two products for use in the treatment for cancer. This number has risen dramatically (40 approvals), with a total of 22 cancer or cancer-related biosimilar products approved since 2015. Recently, the FDA also approved the four interchangeable biosimilar products for diabetes, certain inflammatory diseases, and certain ophthalmic diseases. Given the current market dynamics and the regulatory landscape, this ASCO manuscript now seeks to propose several policy recommendations across the scope of value, interchangeability, clinician barriers, and patient education and access. This policy statement is intended to guide ASCO's future activities and strategies and serves to affirm our commitment to providing education to the oncology community on the use of biosimilars in the cancer setting.
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