Prescription Drug News of Note - November 2017

Prescription Drug News of Note - November 2017

 

 Prescription Drug News of Note September 2017

Each month, we round up the latest FDA approvals and regulations to give you an expert take on what you need to know.

FDA Approves Lyrica CR Tablets for Neuropathic Pain Conditions

Pfizer Inc. announced on October 12th that the United States Food and Drug Administration (FDA) has approved an extended release version of Lyrica, which was first approved by the FDA in December, 2004.  Lyrica CR (pregabalin) extended-release tablets are approved as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of postherpetic neuralgia (PHN). Lyrica CR did not receive approval for the management of fibromyalgia or epilepsy, two indications where Lyrica is currently FDA approved.

Lyrica CR would offer the convenience of once-daily dosing for indications listed above.  Lyrica is believed to work on damaged nerves, or to calm overactive nerves. Effectiveness and safety was established in studies of 801 patients with PHN.

Conversion from LYRICA Capsules or Oral Solution to LYRICA CR

LYRICA Total Daily Dose (dosed 2 or 3 times daily)

LYRICA CR Dose (dosed once a day)

75 mg/daily

82.5 mg/day

150 mg/daily

165 mg/day

225 mg/daily

247.5 mg/daya

300 mg/daily

330 mg/day

450 mg/daily

495 mg/dayb

600 mg/daily

660 mg/dayc

a247.5 mg = 3 x 82.5 mg tablets taken once a day.
b495 mg = 3 x 165 mg tablets taken once a day.
c660 mg = 2 x 330 mg tablets taken once a day.

Extended-release tablets will be available as: 82.5 mg, 165 mg, and 330 mg.

Why is this important?
Pfizer most likely is hoping that current Lyrica users (patent expiration expected Q4 2018) will switch over to the new extended release version, which will have full patent protection for many years to come. Pfizer did not release any information on the cost of the new drug, which is expected to be available in January.

Unlike the original formulation of Lyrica, which is widely prescribed to treat fibromyalgia, Lyrica CR is only approved to treat nerve pain caused by diabetic peripheral neuropathy and postherpetic neuralgia caused by shingles.  There is a possibility that it won’t stop doctors from prescribing Lyrica CR off-label to fibromyalgia and other chronic pain conditions.

Allergan to face a cheaper, compounded version of Restasis eye drops

Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), an ophthalmology-focused pharmaceutical company, announced on October 19th that it is making compounded Cyclosporine-based formulations available for physicians to consider prescribing as customizable and potentially lower-cost alternatives to Restasis®.  Imprimis' Cyclosporine-based compounded formulations, which will be packaged in a multi-use preservative-free bottle, are patent-pending and include "Klarity Drops™," a patented formulation developed by renowned ophthalmologist Richard L. Lindstrom, MD.  

Restasis eye drops are used to treat chronic dry eye that may be caused by inflammation.

Dry Eye Disease is estimated to affect up to 30 million Americans and is commonly characterized by irritated, gritty, scratchy or burning eyes, blurred vision, and feeling particles in the eye when there are none. Advanced Dry Eye Disease may damage the front surface of the eye and ultimately impair vision. The Imprimis Cyclosporine-based formulations, which are made from FDA-approved drug components and compounded in FDA-inspected facilities, require a patient specific prescription and may be customized according to patients' individual needs.

Imprimis, which makes compounded medications for costly prescription drugs, is planning on offering a customizable topical formulation of cyclosporine (chemical used in Restasis).

Why is this important?

San Diego-based Imprimis’ therapy will cost 99 cents for a month’s supply, with refills starting at $79 a month. As a compounded product, the Imprimis product would be subject to any plan rules around compounded products.

Topical Cyclosporine, which is an inexpensive drug, can cost more than $5,000 per year when it is purchased in the commercially available form of Restasis®.   

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Posted by

Irina Prosmushkin

Senior Product Manager
Irina holds a Bachelor Degree in Pharmacy from Temple University, and brings over 17 years of experience bringing healthcare solutions to payers. Irina started her pharmacy career at a leading PBM in 1999, and has held a variety of management roles in mail service pharmacy operations, pharmacy compliance, clinical pharmacy, and clinical support. Irina’s focus at Truveris is to oversee current product offerings with a focus on improving clinical outcomes and managing costs. In the past, Irina held roles at OptumRx, and Express Scripts.