• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Nymalize (nimodipine)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Nymalize (nimodipine)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Nymalize (nimodipine) is an oral solution formulation of nimodipine, a dihydropyridine calcium channel blocker. The precise mechanism of action of nimodipine in reducing the incidence and severity of ischemic deficits in adult patients with SAH from ruptured intracranial berry aneurysms is unknown.

    Nymalize is specifically indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition.

    Nymalize is supplied as a solution for oral administration. Nymalize should only be administered via the oral, nasogastric tube, or gastric tube route. The recommended oral dosage is 20 mL (60 mg) every 4 hours for 21 consecutive days.

    Clinical Results

    FDA Approval
    The safety and efficacy of Nymalize in the treatment of SAH is based on adequate and well-controlled studies of nimodipine oral capsules. Nymalize has comparable bioavailability to nimodipine oral capsules. Nimodipine was shown in 4 randomized, double-blind, placebo-controlled trials to reduce the severity of neurological deficits resulting from vasospasm in patients who have had a recent SAH. The trials used doses ranging from 20-30 mg to 90 mg every 4 hours, with drug given for 21 days in 3 studies, and for at least 18 days in the other. Three of the four trials followed subjects for 3-6 months. Three of the trials studied relatively well patients, with all or most patients in Hunt and Hess Grades I - III (essentially free of focal deficits after the initial bleed). Study 4 studied much sicker patients with Hunt and Hess Grades III - V. Studies 1 and 2: these studies were similar in design, with relatively unimpaired SAH patients randomized to nimodipine or placebo. In each, a judgment was made as to whether any late-developing deficit was due to spasm or other causes, and the deficits were graded. Both studies showed significantly fewer severe deficits due to spasm in the nimodipine group; Study 2 showed fewer spasm-related deficits of all severities. No effect was seen on deficits not related to spasm. Study 3: A total of 554 subjects were enrolled, including SAH patients with all grades of severity (89% were in Hunt and Hess Grades I-III). Subjects were treated with placebo or 60 mg of nimodipine every 4 hours. Outcomes were not defined as spasm related or not but there was a significant reduction in the overall rate of brain infarction and severely disabling neurological outcome at 3 months. Study 4: this study enrolled much sicker patients, (Hunt and Hess Grades III-V), who had a high rate of death and disability, and used a dose of 90 mg every 4 hours, but was otherwise similar to Study 1 and Study 2.. Analysis of delayed ischemic deficits, many of which result from spasm, showed a significant reduction in spasm-related deficits. When data were combined for Study 3 and Study 4, the treatment difference on success rate (i.e., good recovery) on the Glasgow Outcome Scale was 25.3% (nimodipine) versus 10.9% (placebo) for Hunt and Hess Grades IV or V.

    Side Effects

    Adverse effects associated with the use of Nymalize may include, but are not limited to, the following:

    • hypotension
    • headache
    • nausea
    • bradycardia

    Mechanism of Action

    Nimodipine is a dihydropyridine calcium channel blocker. The contractile processes of smooth muscle cells are dependent upon calcium ions, which enter these cells during depolarization as slow ionic transmembrane currents. Nimodipine inhibits calcium ion transfer into these cells and thus inhibits contractions of vascular smooth muscle. The precise mechanism of action of nimodipine in reducing the incidence and severity of ischemic deficits in adult patients with SAH from ruptured intracranial berry aneurysms is unknown.

    Additional Information

    For additional information regarding Nymalize or neurological outcomes and ischemic deficits in adults with SAH, please visit the Arbor Pharma web page.

    Approval Date: 2013-05-01
    Company Name: Arbor Pharmaceuticals
    Back to Listings

    Upcoming Events

    • 16Oct

      MAGI@home Clinical Research Conference 2023

    • 25Oct

      2023 WCG Patient Forum

    • 26Oct

      FDA in 2024: What to Expect in an Election Year

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Donna Snyder

      New WCG Executive Physician Outlines Goals for Clinical Research

    • Hand Shake at Meeting

      Partnership to Bolster Trials in Low Resource Regions Kicks Off

    • Guidelines-360x240.png

      Major Industry Groups Offer Feedback on ICH’s E6(R3) Guidelines

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Monitoring

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing