Navigation Links
Arbor Pharmaceuticals Announces FDA Approval of First NDA
Date:5/13/2013

ATLANTA, May 13, 2013 /PRNewswire/ -- Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Nymalize™ (nimodipine) oral solution. Nymalize was previously granted Orphan designation which provides seven years of market exclusivity. Nymalize is the first and only nimodipine oral solution indicated for the improvement of neurological outcome in adult patients with subarachnoid hemorrhage (SAH).

Prior to the approval of Nymalize, nimodipine was only available in gel capsule form. Since the product is commonly administered to patients through a nasogastric tube, healthcare providers would extract the product from the gel capsule with a syringe. This has resulted in accidental administrations of nimodipine intravenously instead of via the intended enteral (oral) syringe. 

In 2010, the FDA issued a "drug safety communication" to healthcare professionals titled "Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harm." In this communication they reported twenty-five intravenous nimodipine prescribing or administration errors and that four of the patients who mistakenly received nimodipine intravenously died and five had near-death events. The Institute for Safe Medication Practice reported an additional death due to improper nimodipine administration in February 2013.

Ed Schutter , President & CEO of Arbor stated, "I am pleased that Arbor's first NDA approval has the potential to save lives by reducing the opportunity for hospital administration errors.  To further ensure that we minimize the potential for administration error, each Nymalize unit dose cup will be packaged with an oral syringe. Nymalize adds to our growing portfolio of approved prescription products that can improve the lives of our patients."

Dr. Laurence Downey , VP of Medical & Scientific Affairs added, "Approval of our first NDA is an important milestone in the evolution of Arbor Pharmaceuticals. This is the first of what we hope will be multiple NDA approvals over the next several years. I would like to thank and congratulate our team that worked on the Nymalize NDA."

Arbor Pharmaceuticals will launch Nymalize in the next few months. 

About Nymalize
Nymalize (nimodipine) oral solution is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with SAH from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V).

Important Safety Information About Nymalize
Blood pressure should be carefully monitored during treatment with Nymalize (nimodipine) oral solution. Nimodipine may increase the blood pressure lowering effect of concomitantly administered anti-hypertensives such as diuretics, beta-blockers, ACE inhibitors, angiotensin receptor blockers, other calcium channel blockers, alpha-adrenergic blockers, PDE5 inhibitors, and alpha-methyldopa.

Patients with cirrhosis are at a higher risk of adverse reactions and should be monitored closely and administered a lower dose.

Concomitant use of strong inhibitors of CYP3A4 with nimodipine should generally be avoided due to risk of significant hypotension.  These include some macrolide antibiotics (e.g. clarithromycin, telithromycin), some HIV protease inhibitors (e.g., indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (e.g., boceprevir, telaprevir), some azole antimycotics (e.g., ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan, delaviridine, and nefazadone. 

Concomitant use of strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampin, St. John's wort) and nimodipine should generally be avoided, as nimodipine plasma concentration and efficacy may be significantly reduced.

Nimodipine plasma concentration can also be increased in the presence of moderate and weak inhibitors of CYP3A4. If nimodipine is concomitantly administered with these drugs, blood pressure should be monitored, and a reduction of the nimodipine dose may be necessary. 

Grapefruit juice inhibits CYP3A4. Ingestion of grapefruit/grapefruit juice is not recommended while taking nimodipine.

Moderate and weak inducers of CYP3A4 may also reduce the efficacy of nimodipine. Patients on these should be closely monitored for lack of effectiveness, and a nimodipine dosage increase may be required.

Common Adverse Reactions

Most common adverse reactions (incidence >/=1% and >/=1% placebo) were hypotension, headache, nausea, and bradycardia.

About Arbor Pharmaceuticals
Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently focused on the hospital, cardiovascular and pediatric markets. The company has 175 sales professionals in the field which promote its products to hospitals and physicians. Arbor intends to become a leading specialty pharmaceutical company by actively licensing, developing and commercializing late-stage products for specialty focused conditions. Arbor currently markets fifteen NDA and ANDA approved products with twenty-eight more in development.

For more information regarding Arbor Pharmaceuticals or any of its products, visit www.arborpharma.com or send email inquiries to info@arborpharma.com.


'/>"/>
SOURCE Arbor Pharmaceuticals
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Gilead Sciences Supports HarborPaths HIV/AIDS Medication Assistance Pilot Program
2. Kalyspo Awarded Best of Ann Arbor SPARK Boot Camp
3. Developmental Disabilities Software announces Safe Harbor Self-Certification Compliance
4. Thom Rowland Joins Arbor Pharmaceuticals as Vice President of Commercial Operations
5. HarborPath Creates a Single Portal for Uninsured Individuals to Access HIV/AIDS Medications
6. Arbor Pharmaceuticals partners with the Association of Black Cardiologists to further the campaign of "Saving Hearts of a Diverse America"
7. Optimer Pharmaceuticals Appoints Eric Sirota as Chief Operating Officer
8. Valeant Pharmaceuticals To Webcast 2013 Annual Meeting Of Shareholders
9. Isis Pharmaceuticals to Present at the 2013 UBS Global Healthcare Conference
10. Actinium Pharmaceuticals, Inc. Receives Notice of Patent Allowance for a Key Application
11. Valeant Pharmaceuticals International, Inc. Announces Additional Information Regarding Continuance Proposal
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/20/2017)... Feb. 20, 2017   AT&T 1 ... and treat patients with cardiovascular disease faster. The ... for ZywiePro, Zywie,s cardiac remote monitoring solution. The ... . AT&T and Zywie are looking ... with the disease. The Internet of Things (IoT) ...
(Date:2/20/2017)... Feb. 20, 2017 Seal Shield LLC ( ... solution for mobile device management and disinfection, the ElectroClave™, ... and Exhibition in Orlando, Fla. ... Mobile devices have become commonplace in today,s healthcare landscape, ... set of concerns, including the disinfection and tracking of ...
(Date:2/20/2017)... 20, 2017 Research and Markets has announced ... Market Analysis and Trends - Product (RFID refrigerators and RFID freezers), ... report to their offering. ... The Global RFID Blood Refrigerator and Freezer Market ... 2015 to 2025. This industry report analyzes the ...
Breaking Medicine Technology:
(Date:2/18/2017)... ... February 17, 2017 , ... ... drvallecillos.com , Beverly Hills plastic surgeon Dr. Glenn Vallecillos experiments ... Dr. Vallecillos says, "Traditionally, plastic surgery has been centered around that idea that ...
(Date:2/18/2017)... , ... February 18, 2017 , ... ... Use Pixel Film Studios ’ ProParagraph Fashion Volume 2 for all ... many other applications. Users can pick and choose from hand-crafted trend-setting designs ...
(Date:2/17/2017)... ... 2017 , ... Smiles by Seese is a comprehensive family dental practice ... leads the practice as a skilled and highly credentialed dentist who is qualified to ... patients of all ages with excellence in general, restorative, and cosmetic dentistry . ...
(Date:2/17/2017)... Diego, CA (PRWEB) , ... February 17, 2017 ... ... initiative—InvestUp—to focus on foundational and sustainable systems change designed to further positively impact ... , “The Board of Trustees has long considered it our duty to seriously ...
(Date:2/17/2017)... ... February 17, 2017 , ... For the ... management solution to the exhibit floor for the 2017 HIMSS Conference & ... From Feb. 19–23, 2017, more than 40,000 healthcare industry professionals are expected at ...
Breaking Medicine News(10 mins):