By Susan Heavey
WASHINGTON, May 10 (Reuters) - NicOx SA's prescription pain drug appears safe and effective for arthritis patients, but the impact on cardiovascular risks is less clear, U.S. Food and Drug Administration staff reviewers said in documents released on Monday.
The French drugmaker is seeking FDA approval to sell its drug, a non-steroidal anti-inflammatory drug (NSAID) called naproxcinod, to treat osteoarthritis. The company is hoping the agency will recognize the drug's potential blood-pressure benefits, setting it apart from rivals in an already-crowded field.
But an FDA staff reviewer said, based on information to date, the drug's effect on patients' blood pressure is variable.
'Typically, drugs with meaningful effects on cardiac outcomes have an effect on systolic and diastolic (blood pressure) that persists through the dosing interval,' an FDA staff reviewer wrote. 'In this case, the potential impact on cardiac outcomes is unclear.'
Naproxcinod aims to be an improved version of naproxen, a widely used NSAID that can increase blood pressure and cause stomach problems. It is a nitric oxide-releasing version designed to avoid such side effects.
The FDA staff will present their reviews to an FDA panel of outside experts that meets Wednesday to discuss whether the drug is safe and effective for the joint disease.
A final agency decision is due by July 23.
If approved, the drug would be the first approved product for NicOx, which has said it would seek to partner with another pharmaceutical company to sell naproxcinod to U.S. primary care doctors. It would retain co-promotion rights for specialist prescribers.
Analysts are divided as to whether the drug's potential heart benefits could be enough to win over prescribing physicians, especially when generic versions are already available at much lower costs.
AstraZeneca Plc and Pozen Inc also recently won FDA approval for their naproxen-based drug that cuts the risk of developing stomach ulcers, called Vimovo. Non-prescription strength naproxen is sold over the counter as Bayer AG's Aleve.
In separate documents also released on Monday, NicOx said its drug would offer an additional treatment option with the same efficacy and safety as traditional naproxen while mitigating some of the known complications.
'Naproxcinod is less likely to increase (blood pressure) than NSAIDs, which may be of particular importance to (osteoarthritis) patients with pre-existing hypertension,' it wrote.
Pfizer Inc's Celebrex, a different type of pain medicine known as a COX-2 drug, is also a rival.
Shares of the NicOx closed up nearly 5 percent on the Paris exchange.
(Reporting by Susan Heavey; Editing by Steve Orlofsky and Richard Chang) Keywords: NICOX (sheavey@thomsonreuters.com; +1 202-354-5848; www.twitter.com/ReutersDChealth) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
WASHINGTON, May 10 (Reuters) - NicOx SA's prescription pain drug appears safe and effective for arthritis patients, but the impact on cardiovascular risks is less clear, U.S. Food and Drug Administration staff reviewers said in documents released on Monday.
The French drugmaker is seeking FDA approval to sell its drug, a non-steroidal anti-inflammatory drug (NSAID) called naproxcinod, to treat osteoarthritis. The company is hoping the agency will recognize the drug's potential blood-pressure benefits, setting it apart from rivals in an already-crowded field.
But an FDA staff reviewer said, based on information to date, the drug's effect on patients' blood pressure is variable.
'Typically, drugs with meaningful effects on cardiac outcomes have an effect on systolic and diastolic (blood pressure) that persists through the dosing interval,' an FDA staff reviewer wrote. 'In this case, the potential impact on cardiac outcomes is unclear.'
Naproxcinod aims to be an improved version of naproxen, a widely used NSAID that can increase blood pressure and cause stomach problems. It is a nitric oxide-releasing version designed to avoid such side effects.
The FDA staff will present their reviews to an FDA panel of outside experts that meets Wednesday to discuss whether the drug is safe and effective for the joint disease.
A final agency decision is due by July 23.
If approved, the drug would be the first approved product for NicOx, which has said it would seek to partner with another pharmaceutical company to sell naproxcinod to U.S. primary care doctors. It would retain co-promotion rights for specialist prescribers.
Analysts are divided as to whether the drug's potential heart benefits could be enough to win over prescribing physicians, especially when generic versions are already available at much lower costs.
AstraZeneca Plc and Pozen Inc also recently won FDA approval for their naproxen-based drug that cuts the risk of developing stomach ulcers, called Vimovo. Non-prescription strength naproxen is sold over the counter as Bayer AG's Aleve.
In separate documents also released on Monday, NicOx said its drug would offer an additional treatment option with the same efficacy and safety as traditional naproxen while mitigating some of the known complications.
'Naproxcinod is less likely to increase (blood pressure) than NSAIDs, which may be of particular importance to (osteoarthritis) patients with pre-existing hypertension,' it wrote.
Pfizer Inc's Celebrex, a different type of pain medicine known as a COX-2 drug, is also a rival.
Shares of the NicOx closed up nearly 5 percent on the Paris exchange.
(Reporting by Susan Heavey; Editing by Steve Orlofsky and Richard Chang) Keywords: NICOX (sheavey@thomsonreuters.com; +1 202-354-5848; www.twitter.com/ReutersDChealth) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.