Introduction of LYRICA (Pregabalin)

“ LYRICA CR was developed to offer patients an effective treatment option with the convenience of once-daily dosing,” said James M. Rusnak, MD, PhD, Chief Development Officer, Internal Medicine, Pfizer Global Product Development. “It provides an important option for patients and health care providers managing these often debilitating pain conditions.”

Pregabalin, one of the best-selling prescription drugs in the world, is researched and developed by Pfizer, it has been approved by EMA on 6th July 2004, and approved by FDA on 30th Dec 2004. Trade name is LYRICA.

LYRICA is currently approved in the U.S. for fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adults. LYRICA is also approved as adjunctive therapy for the treatment of partial onset seizures in patients four years of age and older.

The most common adverse reactions reported with LYRICA CR were dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth and weight gain.

In 2007, it was awarded one of the top ten medical advances in 2007 by Time Magazine. Since its launch, the global sales of Pregabalin have been on the rise, it becomes one of the best-selling prescription drugs in the world.

At present, the drug has been listed in dozens of countries and regions, which is truly a best-selling drug; pregabalin's compound patent and pain application patent was expired in 2018, and the generic drug market has a huge prospect. 

1.Basic information

2.Global market of Pregabalin

3.Pharmacological action

Pregabalin is a GABA analogue, with similar structure and function to gabapentin, it has antiepileptic, analgesic and anti anxiety activities. The antiepileptic mechanism of pregabalin is still not clear. In laboratory studies, pregabalin has anticonvulsant activity against various epileptic models.

4.Synthesis route

Original research route:

Intermediates list

Non-patent route:

We recommend this route because of the following advantages,

1. Its synthesis route is the shortest, only 4 steps to the Pregabalin finished product.

2. The overall yield is about 30%.

3. Don’t use high toxic reagent during the production.

4. It can be commercialized.

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