NicOx
Encyclopedia
NicOx S.A.
S.A. (corporation)
S.A. designates a particular type of corporation in various countries, mostly those employing the civil law. It originated in Spain during the 16th century. Depending on language, the abbreviation stands for various phrases meaning anonymous society, anonymous company, anonymous partnership, or...

 is a French
France
The French Republic , The French Republic , The French Republic , (commonly known as France , is a unitary semi-presidential republic in Western Europe with several overseas territories and islands located on other continents and in the Indian, Pacific, and Atlantic oceans. Metropolitan France...

 pharmaceutical company. Its headquarters are at Sophia Antipolis
Sophia Antipolis
Sophia Antipolis is a technology park northwest of Antibes and southwest of Nice, France. Much of the park falls within the commune of Valbonne. Created in 1970-84, it houses primarily companies in the fields of computing, electronics, pharmacology and biotechnology. Several institutions of higher...

 (U.S. headquarters in Warren, New Jersey, opened in October 2007). Louis Ignarro
Louis Ignarro
Louis J. Ignarro is an American pharmacologist. He was corecipient of the 1998 Nobel Prize in Physiology or Medicine with Robert F...

, co-recipient of the 1998 Nobel Prize in Physiology or Medicine
Nobel Prize in Physiology or Medicine
The Nobel Prize in Physiology or Medicine administered by the Nobel Foundation, is awarded once a year for outstanding discoveries in the field of life science and medicine. It is one of five Nobel Prizes established in 1895 by Swedish chemist Alfred Nobel, the inventor of dynamite, in his will...

 for demonstrating the signalling properties of nitric oxide
Nitric oxide
Nitric oxide, also known as nitrogen monoxide, is a diatomic molecule with chemical formula NO. It is a free radical and is an important intermediate in the chemical industry...

, is a member of the scientific committee of the company.

The company focuses on the uses of the medical properties of nitric oxide
Nitric oxide
Nitric oxide, also known as nitrogen monoxide, is a diatomic molecule with chemical formula NO. It is a free radical and is an important intermediate in the chemical industry...

. It has several molecules in the pipeline, and its lead compound was an anti-inflammatory
Anti-inflammatory
Anti-inflammatory refers to the property of a substance or treatment that reduces inflammation. Anti-inflammatory drugs make up about half of analgesics, remedying pain by reducing inflammation as opposed to opioids, which affect the central nervous system....

 drug, naproxcinod
Naproxcinod
Naproxcinod is a non-steroidal anti-inflammatory drug developed by the French pharmaceutical company NicOx. It is a derivative of naproxen with a nitroxybutyl ester to allow it to also act as a nitric oxide donor...

, of the CINOD (COX-inhibiting nitric oxide donator) class for the treatment of osteoarthritis
Osteoarthritis
Osteoarthritis also known as degenerative arthritis or degenerative joint disease, is a group of mechanical abnormalities involving degradation of joints, including articular cartilage and subchondral bone. Symptoms may include joint pain, tenderness, stiffness, locking, and sometimes an effusion...

. This class of drugs was first described by John Wallace and colleagues. The company has ongoing development partnerships with Bausch & Lomb
Bausch & Lomb
Bausch & Lomb, an American company based in Rochester, New York, is one of the world's leading suppliers of eye health products, such as contact lenses and lens care products today. In addition to this main activity, in recent years the area of medical technology has been developed...

 and Merck
Merck & Co.
Merck & Co., Inc. , also known as Merck Sharp & Dohme or MSD outside the United States and Canada, is one of the largest pharmaceutical companies in the world. The Merck headquarters is located in Whitehouse Station, New Jersey, an unincorporated area in Readington Township...

.

The market capitalisation of the company was $ 1 billion as of January 2008. It is listed on Euronext
Euronext
Euronext N.V. is a pan-European stock exchange based in Amsterdam and with subsidiaries in Belgium, France, Netherlands, Portugal and the United Kingdom. In addition to equities and derivatives markets, the Euronext group provides clearing and information services...

, the French stock exchange and is part of the CAC Mid 100 stock market index
Stock market index
A stock market index is a method of measuring a section of the stock market. Many indices are cited by news or financial services firms and are used as benchmarks, to measure the performance of portfolios such as mutual funds....

. It has been included in the SBF 120
SBF 120
The SBF 120 is a French stock market index. The index is based on the 120 most actively traded stocks listed in Paris. It includes all 40 stocks in the CAC 40 index plus a selection of 80 additional stocks listed on the Premier Marché and Second Marché under Euronext Paris....

 index since 18 June 2007. Oppenheimer Funds is its first shareholder with 25 % of its capital.

Naproxcinod

Naproxcinod was the company's lead compound until 2011. The company finished three phase III clinical trials. The first of these studies to be published showed that naproxcinod had similar efficacy to naproxen
Naproxen
Naproxen sodium is a nonsteroidal anti-inflammatory drug commonly used for the reduction of pain, fever, inflammation and stiffness caused by conditions such as:...

 (measured in WOMAC
WOMAC
The Western Ontario and McMaster Universities Arthritis Index is a set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. It can be self-administered and was developed at Western Ontario and McMaster Universities...

 Pain, function and patient global assessment) in controlling signs and symptoms of osteoarthritis
Osteoarthritis
Osteoarthritis also known as degenerative arthritis or degenerative joint disease, is a group of mechanical abnormalities involving degradation of joints, including articular cartilage and subchondral bone. Symptoms may include joint pain, tenderness, stiffness, locking, and sometimes an effusion...

. It has been well documented that non-steroidal anti-inflammatory drug
Non-steroidal anti-inflammatory drug
Nonsteroidal anti-inflammatory drugs, usually abbreviated to NSAIDs or NAIDs, but also referred to as nonsteroidal anti-inflammatory agents/analgesics or nonsteroidal Anti-inflammatory medicines , are drugs with analgesic and antipyretic effects and which have, in higher doses, anti-inflammatory...

s increase blood pressure
Blood pressure
Blood pressure is the pressure exerted by circulating blood upon the walls of blood vessels, and is one of the principal vital signs. When used without further specification, "blood pressure" usually refers to the arterial pressure of the systemic circulation. During each heartbeat, BP varies...

, and naproxen is one of the safest in this regard. Meanwhile naproxcinod had similar effects on blood pressure to placebo
Placebo
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient...

 (which is considered neutral), while the comparator naproxen (sold under the brand Aleve in the United States) showed a statistically significant increase in blood pressure. This difference was especially marked for those patients taking RAS blockers (ACE inhibitor
ACE inhibitor
ACE inhibitors or angiotensin-converting enzyme inhibitors are a group of drugs used primarily for the treatment of hypertension and congestive heart failure...

s, ARBs
Angiotensin II receptor antagonist
Angiotensin II receptor antagonists, also known as angiotensin receptor blockers , AT1-receptor antagonists or sartans, are a group of pharmaceuticals which modulate the renin-angiotensin-aldosterone system...

 and beta blocker
Beta blocker
Beta blockers or beta-adrenergic blocking agents, beta-adrenergic antagonists, beta-adrenoreceptor antagonists or beta antagonists, are a class of drugs used for various indications. They are particularly for the management of cardiac arrhythmias, cardioprotection after myocardial infarction ,...

s). This means that naproxcinod could have become an option for patients with osteoarthritis who needed to take NSAIDs.

In September of 2009, NicOx filed for regulatory approval
Approved drug
In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo an extensive FDA approval process. This process involves first testing the drug on animals or in medical labs. If found to be safe by the FDA and approved for the next phase of study, the drug is then...

 of naproxcinod
Naproxcinod
Naproxcinod is a non-steroidal anti-inflammatory drug developed by the French pharmaceutical company NicOx. It is a derivative of naproxen with a nitroxybutyl ester to allow it to also act as a nitric oxide donor...

 with the United States Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

 (FDA) and the European Medicines Agency
European Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...

. On 12 May 2010, an FDA advisory committee voted against approval, questioning the safety of the drug. NicOx has appealed this decision. Subsequently, in April 2011, the company withdrew its European application after it became clear that an EU expert panel was going to fail to render a positive review of NicOx's clinical data.

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