Navigation Links
Nautilus Neurosciences and Tribute Pharmaceuticals Announce Exclusive Canadian License for CAMBIA™ (diclofenac potassium for oral solution) for the Acute Treatment of Migraine
Date:11/16/2010

BEDMINSTER, N.J., and MILTON, Canada, Nov. 16, 2010 /PRNewswire/ -- Nautilus Neurosciences, Inc., a neurology-focused specialty pharmaceutical company, and Tribute Pharmaceuticals, a privately-held Canadian specialty pharmaceutical company, announced today their exclusive license agreement for the commercialization of CAMBIA™ (diclofenac potassium for oral solution) in Canada.  CAMBIA™ is approved in the United States for the acute treatment of migraine with or without aura and was launched in the United States in June 2010.  

"Canada is an important pharmaceutical market and opportunity for CAMBIA," said James Fares, Chairman and CEO, of Nautilus Neurosciences. "The management team at Tribute Pharmaceuticals has a wealth of experience in developing, launching and successfully commercializing new products in Canada.  This partnership along with recent developments in the US has significantly enhanced our ability to market CAMBIA™ to the broader North American market and reach more people suffering from acute migraine headaches.  We look forward to completing the expansion of our efforts through the addition of a partner for the family practice market in the United States in 2011."

Rob Harris, President & CEO of Tribute Pharmaceuticals points out that, "According to IMS, the prescription drug market in Canada for treating migraine headaches is valued at approximately one hundred and fifty million dollars."  Many Canadians who suffer from migraines are dissatisfied with their current medication and hope for a better treatment.  "Tribute Pharmaceuticals is very excited about the potential for CAMBIA™ in Canada and we look forward to building a strong partnership with Nautilus Neurosciences."

According to a survey published in the Journal of the American Board of Family Medicine, many people still hope to find a better treatment for their migraines, with more than a quarter dissatisfied with their treatment and fewer than a fifth of people who suffer migraines describing themselves as "very satisfied" with their treatment.

A novel, water-soluble, buffered diclofenac potassium powder, CAMBIA™ is the only prescription non - steroidal anti-inflammatory drug (NSAID) available for the acute treatment of migraine.  Engineered using Dynamic Buffering Technology™ (DBT), a patented absorption-enhancing technology developed by APR Applied Pharma Research S.A., CAMBIA™ is specifically designed for fast, effective relief from the symptoms of migraine. CAMBIA™ enters the bloodstream quickly and readily achieves peak plasma concentrations, providing pain relief in fifteen minutes for some patients.

About Nautilus Neurosciences, Inc.

Nautilus Neurosciences is a neurology-focused specialty pharmaceutical company committed to providing the health care community with medically relevant products and services that directly benefit those affected by neurologic disorders.  Nautilus is backed by Tailwind Capital and Galen Partners.  

For more information, please visit www.nautilusneurosciences.com.

About Tribute Pharmaceuticals, Inc.

Tribute Pharmaceuticals is a specialty pharmaceutical company engaged in the acquisition, licensing and management of pharmaceuticals products in Canada. Tribute is committed to providing patients and physicians with clinically proven pharmaceuticals products that treat recognized medical conditions and diseases.  Tribute Pharma is a privately held Canadian company.  For more information please visit http://www.tributepharma.ca.

Unites States Indication

CAMBIA is a non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older.

CAMBIA is not indicated for prophylactic therapy or for cluster headache.

Important Safety Information (United States)

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS NSAIDs, including CAMBIA, may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use or in patients with CV disease or risk factors for CV disease. CAMBIA is contraindicated for peri-operative pain in coronary artery bypass graft surgery. NSAIDs increase the risk of gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk.

Use the lowest effective dose for the shortest possible duration. Long-term administration of NSAIDs can result in serious and potentially fatal events, including CV thrombotic events or GI reactions.

CAMBIA is contraindicated in patients with hypersensitivity to diclofenac or other NSAIDs, and in patients with preexisting asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic-like reactions have been reported in such patients. Anaphylactic reactions may also occur in patients with the aspirin triad or in patients without prior exposure to CAMBIA. CAMBIA is contraindicated in patients with the aspirin triad. Discontinue immediately if an anaphylactic reaction occurs.

Renal papillary necrosis and other renal injury may occur with long-term use of NSAIDs. Use CAMBIA with caution in patients at risk, including the elderly, those taking diuretics or ACE inhibitors, those with renal impairment, heart failure, or liver impairment. CAMBIA is not recommended in patients with advanced renal disease.

Use caution when prescribing CAMBIA with drugs known to be hepatotoxic (eg, acetaminophen, certain antibiotics, antiepileptics). Warn patients to avoid acetaminophen containing products while taking CAMBIA. The liver metabolizes almost 100% of diclofenac, and there is insufficient information to support dosing recommendations in patients with hepatic insufficiency. Hepatic effects range from transaminase elevations to liver failure. Discontinue CAMBIA immediately if abnormal liver tests persist or worsen.

NSAIDs can lead to new onset or worsening of preexisting hypertension. Monitor blood pressure closely during therapy. Patients taking ACE inhibitors, thiazides, or loop diuretics may have impaired response to these therapies when taking NSAIDs. Note that fluid retention and edema have been observed in some patients taking NSAIDs. Use CAMBIA with caution in patients with fluid retention or heart failure.

Using CAMBIA with other NSAIDs (eg, aspirin) or with anticoagulants (eg, warfarin) is not advised due to increased risk of serious adverse events, such as GI bleeding. Use with caution in patients with a history of ulcers or GI bleeding. Anemia may occur in patients on NSAIDs. In patients on long-term therapy, check hemoglobin or hematocrit upon any sign or symptom of anemia or blood loss.

NSAIDs, including CAMBIA, can cause serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. Discontinue use immediately if rash or other signs of local skin reaction occur.

CAMBIA can harm fetuses. Starting at 30 weeks' gestation, pregnant women should avoid CAMBIA and other NSAIDs as premature closure of the ductus arteriosus in the fetus may occur. Use with caution in nursing mothers as it is not known if diclofenac is excreted in human milk.

The most common adverse events in clinical trials with CAMBIA were nausea and dizziness.


'/>"/>
SOURCE Nautilus Neurosciences, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Nautilus Neurosciences and Mission Pharmacal Announce Exclusive Co-Promotion Agreement for CAMBIA™ (diclofenac potassium for oral solution) for the Acute Treatment of Migraine to the Womens Health Market
2. US WorldMeds Acquires Solstice Neurosciences
3. Blanchette Rockefeller Neurosciences Institute and Inverness Medical Innovations to Develop Commercial Test to Detect Early Alzheimers Disease
4. Intellect Neurosciences, Inc. Announces Independent Studies on Copper Binding Properties of its Lead Candidate OXIGON(TM)
5. Neurosciences Institute Discovers Drug Extends Stroke Treatment Time to 24 Hours, Repairs Brain Tissue
6. Intellect Neurosciences, Inc. and Medical Research Council Technology (U.K.) Reach Important Milestone in Generating an Alzheimers Therapeutic Antibody
7. Knopp Neurosciences Receives Orphan Designation for KNS-760704 for Treatment of ALS
8. Knopp Neurosciences Initiates Phase 1 Clinical Trial of KNS-760704 in ALS Development Program
9. Intellect Neurosciences, Inc. and CHDI, Inc. Enter Into Compound Testing Agreement to Evaluate OXIGON(TM) as a Potential Treatment for Huntington Disease
10. Intellect Neurosciences, Inc. to Present Data on Alzheimers Vaccine at 13th International Congress of Immunology Conference
11. Onyx Pharmaceuticals Reports Third Quarter 2010 Financial Results; Japan License Leverages Worldwide Potential of Carfilzomib and Contributes $59.2 Million of License Revenue
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... ORANGE COUNTY, Calif. , Oct. 10, 2017  NDS received ... Mobile  — a medical-grade battery-powered display stand specifically designed for ... aims to transform technology into a clinical solution to support the ... costs. Innovative Design ... NDS ZeroWire Mobile Wireless Solution ...
(Date:10/7/2017)... IRVING, Texas , Oct. 6, 2017   ... industry with more than $100 billion in purchasing power, ... industry news and information. The Newsroom is ... chain and industry trends, infographics, expert bios, news releases, ... Besides having access to a wealth of resources at ...
(Date:10/4/2017)...  South Korean-based healthcare product Development Company I.M. Lab ... Kickstarter. The device will educate the user about ,proper, ... efficiency compared to the dated and pricey CPR training ... of the compression for a more informed CPR training. ... raise $5,000. cprCUBE ...
Breaking Medicine Technology:
(Date:10/13/2017)... NJ (PRWEB) , ... October 13, 2017 , ... Global ... at scenic Alexandria Park in Milford, NJ. This free event, sponsored by Global ... physical activity. The fun run is geared towards children of all ages; it ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... giving viewers the lowdown on sciatica in a new episode of "Success Files," ... on current events and innovation and investigates each subject in-depth with passion and ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains ... possible to save lost souls in the Philippines. “The Journey: From the Mountains to ... dedicated teacher of the Bible. She has taught all ages and currently teaches a ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... services for healthcare compliance program management, will showcase a range of technology and ... for Assisted Living (NCAL) Convention and Expo to be held October 14–18, 2017 ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... Planet Fitness, ... the U.S., announced today its plans to open a flagship location in Covington, LA ... the former Rooms To Go store next to Office Depot in the Holiday Square ...
Breaking Medicine News(10 mins):