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FDA Approves Gralise (gabapentin); Abbott

30-Nov-2011

 

For the treatment of postherpetic neuralgia by Abbott; Approved February 2011

 

General Information

Gralise is an extended release formulation of the approved drug gabapentin, developed on DepoMed's Gastric Retention technology. Gabapentin is a gamma-aminobutyric acid (GABA), analogue. The mechanism of action by which gabapentin exerts its analgesic action is unknown but in animal models of analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli).

Gralise is specifically indicated for the management of postherpetic neuralgia.

Gralise is supplied as a tablet for oral administration. Gralise should be titrated to an 1800 mg dose taken orally once daily with the evening meal. The recommended titration schedule is Day 1: 300mg; Day 2: 600mg; Days 3-6: 900mg; Days 7-10: 1200mg; Days 11-14: 1500mg and Day 15: 1800mg.


Side Effects

Adverse events associated with the use of Gralise may include, but are not limited to, the following:

  • dizziness
  • somnolence
  • headache
  • peripheral edema
  • diarrhea

 

Mechanism of Action

Gralise is an extended release formulation of the approved drug gabapentin, developed on DepoMed's Gastric Retention technology. Gabapentin is a gamma-aminobutyric acid (GABA), analogue. The mechanism of action by which gabapentin exerts its analgesic action is unknown but in animal models of analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli).

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