When was Lyrica (pregabalin) approved?

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Last updated: February 26, 2025View editorial policy

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From the Research

Lyrica (pregabalin) was first approved by the FDA in December 2004 for the treatment of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. This approval is based on the evidence from studies such as 1, which highlights the efficacy of pregabalin in managing neuropathic pain. The medication was later approved for additional indications, including partial onset seizures in 2005, as noted in 2.

Key Points

  • Pregabalin is a gamma-aminobutyric acid analogue that works by binding to calcium channels in the nervous system, reducing the release of excitatory neurotransmitters involved in pain transmission and seizures, as explained in 3.
  • The medication has demonstrated efficacy in the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and as adjunctive therapy for adult patients with partial onset seizures, as shown in 4.
  • Pregabalin became available as a generic medication in the United States in 2019, making the treatment more accessible to patients through lower-cost alternatives.

Mechanism of Action

Pregabalin's mechanism of action involves binding to the alpha2-delta subunit of voltage-gated calcium channels, which reduces the synaptic release of several neurotransmitters, as discussed in 3. This action apparently accounts for its effects in reducing neuronal excitability and seizures.

Clinical Use

The clinical use of pregabalin includes the treatment of neuropathic pain, partial onset seizures, and generalized anxiety disorder, as noted in 5. The medication has been shown to be effective in reducing pain and improving sleep in patients with neuropathic pain, and in reducing seizure frequency in patients with partial onset seizures.

Safety and Tolerability

Pregabalin is generally well-tolerated, with common adverse effects including dizziness, somnolence, and headache, as reported in 1. The medication has been designated as a Schedule V controlled substance due to its potential for abuse and dependence.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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