Last year, Lyrica (pregabalin) was pharmaceutical giant Pfizer Inc.’s second best-selling prescription drug, with sales totaling $4.6 million. The medication is classified as an antiepileptic drug, aka an anticonvulsant. But it is also prescribed as a pain reliever. Its popularity with physicians can be partially attributed to the fact that the medication is one of the few non-opioid, non-acetaminophen, non-NSAID options for chronic pain relief. Pregabalin is classified as a Schedule V controlled substance and available by prescription only.
What does Lyrica treat?
In 2005, the U.S. Food and Drug Administration (FDA) approved the medication to treat neuropathic pain and damage due to diabetes or shingles, fibromyalgia (a condition characterized by chronic, widespread pain), spinal cord injury, and seizures. Since then, it has been prescribed to more than 16 million people in the United States.
How much does Lyrica cost?
It’s a hefty price. Without insurance, brand name Lyrica costs between $460 to $720 per month, depending on dosage and quantity.
When did Lyrica go generic?
On July 22, 2019, the FDA approved 9 generic drug applications for versions of pregabalin—the non-name brand version of the medication. Approvals for the generic versions of Lyrica were granted to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Inc., Sciegen Pharmaceuticals Inc., and Teva Pharmaceuticals—in hopes that creating generic versions of Lyrica can improve patient access to affordable alternatives to the medication.
How much does Lyrica generic cost?
Retail prices of the generic pregabalin range between $140 and $370 per month. Your copay could be even less with your insurance plan or a prescription discount card, like SingleCare.
Why is generic Lyrica less expensive?
It’s about supply and demand. The availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to health care for more patients, according to Sandy Walsh, press officer at the FDA.
But how can one company distribute the same medication at a lower cost and still profit? That’s all part of the development process, Walsh explains. “Creating a drug costs lots of money,” she says. “Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less. But they must show that their product performs in the same way as the brand-name drug.” While a new, brand name drug goes through a lengthy process of applications and clinical trials for safety and efficacy, the generic manufacturer files an Abbreviated New Drug Application, or ANDA.
And while the side effects of Lyrica are well known (and oft-covered in the news), the FDA requires that pregabalin be dispensed with a patient medication guide that contains important health information and medical advice about its uses and risks.
The potential side effects of pregabalin include the possibility of an angioedema allergic reaction (swelling of the face, throat, head, and neck, which can cause life-threatening respiratory failure requiring emergency treatment); hypersensitivity reactions such as hives, dyspnea (difficulty breathing), and wheezing; and an increased risk of seizures if the drug is rapidly discontinued. Additionally, all antiepileptic drugs like pregabalin put users at the risk of psychological side effects such as the increased risk of suicidal thoughts or behavior. However, the most common side effects reported during use of Lyrica (and its generic, pregabalin) are dizziness, drowsiness, dry mouth, swelling, blurred vision, weight gain, and abnormal thinking (primarily difficulty with concentration/attention).
When will generic Lyrica be available?
Generic Lyrica is available with a prescription in the U.S. in eight strengths (25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg). It is also available in liquid form. The next time you call your local pharmacy to refill your Lyrica prescription, ask your pharmacist if you can switch to pregabalin.