Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Janssen/Shire Reminyl

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Galantamine was shown to "significantly benefit the cognitive, functional and behavioral symptoms of AD" relative to placebo in a five-month study of 978 patients with mild to moderate Alzheimer's, Janssen investigators reported at the Sixth International Springfield Symposium in Stockholm, Sweden. The study randomized patients to placebo or one of three Reminyl dose regimens: 8 mg/day for the five-month period; 8 mg/day for four weeks followed by 16 mg/day for 17 weeks; and 8 mg/day for four weeks, followed by 16 mg/day for four weeks and 24 mg/day for 13 weeks. Most patients received concomitant medication. Efficacy measurements included the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog), the Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus), the Alzheimer's Disease Cooperative Study Activities of Daily Living inventory (ADCS-ADL), and the Neuropsychiatric Inventory (NPI). The intent-to-treat analysis for ADAS-cog showed mean changes from baseline of 1.7 for placebo patients, 0.4 for 8 mg, and -1.4 for the 16 and 24 mg doses. Changes from baseline on the ADCS-ADL mean scores were -3.8 for placebo vs. -3.2 for 8 mg, -0.7 for 16 mg and -1.5 for 24 mg, investigators reported. The number of patients improving or showing no change on the CIBIC-plus measure was 49% for placebo, 53% for 8 mg, 66% for 16 mg, and 64% for 24 mg. The mean change from baseline for the NPI measure was 2.0 for placebo, 2.3 for 8 mg, -1.0 for 16 mg, and 0 for 24 mg. The study also showed that tolerability of galantamine is optimized by gradual dose escalation. Adverse events, which included nausea, anorexia, agitation and diarrhea, were mostly "mild and transient," according to an abstract. Janssen filed an NDA for galantamine in September 1999, and results from the 978-patient study were submitted as an NDA amendment in February

You may also be interested in...

Ready, Set, Guidance: FDA Releases Final Details Ahead Of ASCA Pilot Launch

A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.

With Preservative-Free Alaway Eye Drops, Bausch Expands OTC Portfolio Of Planned Spin-Off

Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals. 

In US, Market Exclusivity For NDI Notifications ‘Just Not There’ In DSHEA Regulation

Unfounded expectation some firms have for FDA to protect their investments in preparing successful NDI notifications is part of industry’s overall interest in increased regulation of the market, says Steven Tave, Office of Dietary Supplement Programs director.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts