FDA Approves First Generics of Lyrica
The agency's move opens the door to more versions of the neuropathic pain reliever.
The FDA recently approved 9 generic versions of Lyrica (pregabalin), the commonly used and expensive neuropathic pain reliever. The generic approvals 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.
Pregabalin must be dispensed with a patient medication guide containing important information about its uses and risks. Warnings include hypersensitivity reactions such as dyspnea, hives, and wheezing; increased seizure frequency if the drug is rapidly discontinued; and risk of angioedema. The most common adverse effects reported in clinical trials for Lyrica in adults are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain, and abnormal thinking, primarily difficulty with attention and concentration.1
THE BRAND NAME
Lyrica, a prescription nerve and muscle pain reliever, has been criticized frequently in the drug pricing debate. According to the results of a study tracking drug price changes between 2012 and 2017, Lyrica was 1 of 17 drugs (35% of those included in the study) that more than doubled in cost during that period.2
The price of Lyrica has risen steadily since its FDA approval in 2004. At its lowest, the average patient out-of-pocket cost was about $28 in 2008. As of 2016, that amount has hovered between $45 and $50.3
During the same period, the number of Lyrica prescriptions has fluctuated. In 2006, there were about 4 million prescriptions. This amount peaked in 2014 at about 11 million before dropping to 9 million in 2016. It has consistently ranked in the top 100 most prescribed drugs since 2008, ranging from 91st in 2008 to 73rd in 2014.3 Therefore, as one of the most commonly used drugs, the introduction of 9 generics for Lyrica could signal an important change in the landscape of neuropathic pain management.
OPPORTUNITY FOR GENERIC NEUROPATHIC PAIN RELIEVERS
The generics for Lyrica are indicated as an adjunctive therapy for the treatment of partial-onset seizures in patients 17 and older; for neuropathic pain associated with illnesses, such as diabetic peripheral neuropathy, fibromyalgia, and postherpetic neuralgia; and for management of neuropathic pain associated with spinal cord injury.2 Neuropathic pain affects 7% to 10% of the general population and is likely to increase, according to 2016 study results.4
IQVIA has estimated that pregabalin capsules had an estimated market share of $5.47 billion in the United States for the 12 months ended December 2018, according to a statement by Alembic Pharmaceuticals.5 With such a large portion of the market and the possibility for it to grow, access to generic forms of neuropathic pain relievers is increasingly vital to patients’ quality of life and ability to treat their illnesses.
Promoting generic competition is part of the FDA’s Drug Competition Action Plan. In a statement, the agency said that its approval of generics for Lyrica feeds into its goal of improving patient access to more affordable medicines.
“Over the last decade alone, competition from safe and effective generic drugs has saved the health care system about $1.67 trillion,” former FDA Commissioner Scott Gottlieb, MD, said in a statement about the agency’s Drug Competition Action Plan.
“When generics are dispensed at the pharmacy, the immediate savings to each of us are clear,” he said. “We could see even greater cost savings if we helped more safe and effective generic drugs get to market sooner, after patent and statutory exclusivity periods have lapsed, by addressing some of the scientific and regulatory obstacles to generic competition across the full range of FDA-approved drugs.”6
Broadening access to neuropathic pain relief drugs is vital to improving quality of life for patients, and with the introduction of generic Lyrica into the market, even more patients will be able to achieve relief from their pain symptoms.
- FDA approves first generics of Lyrica [news release]. Silver Spring, MD: FDA; July 22, 2019. www.fda.gov/news-events/press-announcements/fda-approves-first-generics-lyrica. Accessed July 29, 2019.
- Wineinger NE, Zhang Y, Topol EJ. Trends in prices of popular brand-name prescription drugs in the United States. Jama Network Open. 2019;2(5):e194791. doi: 10.1001/jamanetworkopen.2019.4791.
- Kane SP. Pregabalin. ClinCalc website. clincalc.com/DrugStats/Drugs/Pregabalin.[MS1] Accessed July 29, 2019.
- Colloca, L, Ludman T, Bouhassira D, et al. Neuropathic pain. Nat Rev Dis Primers. 2017;3:17002. doi: 10.1038/nrdp.2017.2.
- Alembic Pharmaceuticals receives USFDA approval for pregabalin capsules [news release]. Vadodara, India: Alembic Pharmaceuticals; July 22, 2019. alembicpharmaceuticals.com/wp-content/uploads/2019/07/Press-Release-USFDA-Approval-Pregabalin-Capsules.pdf. Accessed July 29, 2019.
- FDA working to lift barriers to generic drug competition [news release]. Silver Spring, MD: FDA; June 21, 2019. www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-working-lift-barriers-generic-drug-competition. Accessed July 29, 2019.