Lyrica (Pregabalin) in Dano Health view
Pregabalin, marketed under the brand name Lyrica, is developed by Pfizer; this medication is used to treat epilepsy, neuropathic pain, fibromyalgia, and generalized anxiety disorder.
Lyrica is an anticonvulsant medicine and a compound related to Pfizer’s hugely successful antiepileptic drug gabapentin (Neurontin) that reduces the number of pain signals from damaged nerves.
In 1990: Pregabalin was synthesized as an anti-seizure drug. Medicinal chemist, Richard Bruce Silverman, invented it at Northwestern University in Evanston, Illinois; It was developed by Parke-Davisit as a successor to gabapentin; Pfizer as the main Lyric supplier brought it to market after acquiring Warner-Lambert.
In 2004: it was approved in the European Union; the FDA approved it in The US for treating epilepsy, diabetic neuropathic pain, and post-herpetic neuralgia. Pregabalin is the first FDA-approved treatment for neuropathic pain states.
In 2005: it appeared on the US market under the brand name Lyrica.
In 2005: Lyrica was approved by the FDA granted approval for adjunctive treatment of partial epileptic seizures in adults.
In June 2007: Lyrica became the first drug to be approved by the FDA for the treatment of fibromyalgia.
Lyrica is an oral medication used in treating:
- Pain from nerves damaged by shingles, a rash that occurs after infection with the herpes zoster virus (Post-Herpetic Neuralgia)
- Fibromyalgia, a chronic condition that may cause pain, muscle stiffness, fatigue, and trouble sleeping
- Adjunctive therapy for the treatment of partial onset seizures in patients 4 years of age and older
Lyrica, a compound with both analgesic and anticonvulsant properties, was developed by Pfizer as a more potent successor to Neurontin.
The exact mechanism of action has not been fully known but according to the preclinical findings, it helps to reduce the abnormal neuronal excitability through reducing neurotransmitter release. Apparently, it binds to an a-2-d site that is an auxiliary subunit of voltage-gated calcium channels in CNS tissues and reduces neuronal excitability and seizures. In fact, it functions mechanistically to reduce the pain. It’s believed that this anti-seizure drug binds to a part of the nerves and reduces the nerves’ ability to send pain messages to each other; it slows down impulses in the brain that cause seizures and also has a noticeable effect on the chemicals in the brain that sends pain signals across the nervous system.
Clinical trial and New Generics Version
Many generic companies are eagerly awaiting Lyrica’s patent expiry; they are working on different clinical trials for producing the generic version of this drug. The main reason for this eagerness is the commercial success of Lyrica. So in the near future, the central nervous system market will see a significant shift.
Consilient Health, the manufacturer of generic and specialty pharma products, has launched Rewisca as its generic version of Lyrica (pregabalin). Clinical trial product suppliers have supplied Lyrica for companies such as Consilient Health in order to research on it. This company has produced the first generic version of Lyrica.
There will be no generic version available in the United States until 2018 but there is a generic version is in Canada, the United Kingdom, Australia, and Germany. Once after approval of generic manufacture of gabapentin, sales of Pfizer’s Neurontin are likely to fall dramatically. An important strategy in minimizing the impact of generic competition will be encouraging physicians to switch patients from Lyrica (Pregabalin) to Neurontin, but it all depends on the approval of Neurontin.
After the FDA approval of Lyrica in 1990, Pfizer brought it to market as a follow-up brand to gabapentin (Neurontin). The company has also engaged in extensive direct-to-consumer advertising campaigns since 2008 so that to promote its branded product Lyrica for fibromyalgia and diabetic nerve pain indications.
The value of the Global painful diabetic neuropathy drugs (PDN) market accounted to US$ 4,811.8 Mn in 2017 and it’s projected to attain a value of US$ 8,962.0 Mn by 2026 at a CAGR of 6.6% during the next years. The ever-growing pool of geriatric population with diabetes is the primary driver of the market growth. Availability of approved drugs and the presence of extensive diabetic patient pool are the other drives that contributed to the overall market growth.
There are only four drugs currently approved for the management of PDN that are Lyrica, Cymbalta, Nucynta, and Qutenza; so there is a huge opportunity for new and emerging market players with potential pipeline portfolio. Among these marketed products, Lyrica accounted for a maximum market share in 2017 and will continue the similar trend through 2026; so Lyrica seller will see significant profit in this market.
With diabetes changing to a global concern, PDN drugs market comprises a worldwide outreach. In 2017, North America dominated the market and expected to maintain its position throughout 2018-2026. Due to the growing awareness of PDN and the rise in healthcare expenditure, Asia Pacific exhibited the fastest CAGR during the mentioned period. Turkish pharmaceutical suppliers also experience fast growth in the Lyrica market.
In the below figure, the sales for Lyrica and Pregabalin generics in the seven major markets (US, 5EU, and Japan) and India and China are shown during 2012-2022.
It’s expected that sales of Lyrica and Pregabalin generics decrease from $121.2m in 2012 to $83.5m in 2022 at a negative compound annual growth rate (CAGR) of 3.7%. A major driver of Lyrica and Pregabalin generics sales during 2012-2022 is the Pfizer’s historical strength in marketing. The patent will expire in the US in 2018 and it was expired in EU in 2013; Entry of newer and more efficacious anti-epileptic drugs (AEDs) into the market are major barriers of Lyrica and Pregabalin generics sales over this period.