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Exalgo. Exalgo has been recently approved by FDA

Mar.07, 2010

US Food and Drug Administration USA (FDA) approved the drug Exalgo (hydromorphone HCl) in the form of delayed release tablets for the treatment of moderate and severe pain.

Currently, a lot of people suffer from moderate to severe chronic pain caused by low-back pain, neck pain and trauma. In fact, physicians frequently try many types of narcotic analgetics (pain killers) before finding an appropriate dose regimen that will provide expected analgesic effect. The active ingredient of Exalgo – hydromorphone Hcl has been used in clinical trials since 1930th and soon will be available in the form of extended release tablets. This will significantly happen to choose the appropriate dose for a short period of time and avoid multiply combinations of pain killers.
Exalgo is taken once daily to control and relieve severe or moderate pain in those patients with tolerance to opioids which require all day long opioid analgesic effect.
Exalgo possesses a specific osmotic delivery system, OROS ® Push-Pull, which allows ещ release hydromorphone at a constant controlled level.

It is expected that Exalgo will be launched on pharmaceutical market in the first half of 2010 and also will include a special risk management program (REMS). This program involves the creation of a special booklet for patients and medical staff training plan for safe use of the drug.

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