Neuropathic Pain Associated With Spinal Cord Injury (NeP SCI)

EFFICACY IN NeP SCI
In a 16-week study, LYRICA (pregabalin) provided significant relief of NeP SCI1,2
lyrica-neuropathic-chart
*LYRICA 150 mg/day to 600 mg/day, divided BID.
Baseline observation carried forward (BOCF) analysis of intent-to-treat population.
For some patients, LYRICA provided a 13% reduction in pain as early as Week 1 vs 5% for placebo (P=.0001)2†
LYRICA: n=111; 150 mg/day to 600 mg/day, divided BID. Placebo: n=108.
Study description
Adapted from Cardenas et al. Neurology. 20131; Pfizer data on file.2
Results from a 16-week, randomized, double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study of 219 patients with neuropathic pain associated with traumatic and nontraumatic spinal cord injury. Patients had pain for an average of 8 years. Eligible subjects had to be experiencing pain below the level of their injury. Subjects were randomized to receive LYRICA 150, 300, 450, or 600 mg/day divided BID, or placebo.
The primary efficacy measure was duration-adjusted average change in pain, defined as: (weighted mean of all daily pain scores post baseline minus mean baseline pain score) x (total post baseline days/planned study duration). Pain was assessed on an 11-point scale. Mean pain scores for LYRICA and placebo were, respectively: 6.5 and 6.5 baseline, and 4.6 and 5.3 at endpoint.
In a 12-week study, LYRICA provided significant relief of NeP SCI2,3
*LYRICA 150 mg/day to 600 mg/day, divided BID.
Baseline observation carried forward (BOCF) analysis of intent-to-treat population.
For some patients, LYRICA provided a 21% reduction in pain as early as Week 1 vs 4% for placebo (P<.0001)2†
LYRICA: n=69; 150 mg/day to 600 mg/day, divided BID. Placebo: n=67.
Study description
DOSING IN NeP SCI
Consider your next steps for LYRICA titration, based on efficacy and tolerability
Dosage may be increased to 300 mg/day based on efficacy and tolerability within 1 week
Patients may be titrated to 600 mg/day if they are not experiencing sufficient pain relief after 2 to 3 weeks of treatment with 300 mg/day
When discontinuing LYRICA, taper gradually over a minimum of 1 week
Adjust the LYRICA daily dose based on renal function
SAFETY IN NeP SCI
In controlled NeP SCI trials,
Adverse reactions were generally mild to moderate
*LYRICA 150 mg/day to 600 mg/day, divided BID.
Additional Information
LYRICA treatment may cause weight gain. In 2 controlled clinical LYRICA NeP SCI trials, 3.3% of LYRICA patients experienced an increase in weight vs 1.1% of the placebo group
  • In both trials, mean change from baseline was up to 4.4 lb for LYRICA patients, vs -1.8 lb for placebo patients1,3
In 2 clinical trials of patients with NeP SCI, 13% of patients treated with LYRICA and 10% of patients treated with placebo discontinued due to adverse reactions
  • The most common reasons for discontinuation of LYRICA-treated patients in NeP SCI trials due to adverse reactions were somnolence (3%) and edema (2%), vs no discontinuations due to these reactions for placebo-treated patients
Clinical Background
With the Co-Pay Savings Card, eligible patients pay as little as $4 per Rx for branded LYRICA
Includes patients who received any study dose of LYRICA in placebo-controlled studies of fibromyalgia, painful diabetic peripheral neuropathy, postherpetic neuralgia, and neuropathic pain associated with spinal cord injury, as well as open-label extensions of those studies.
References: 1. Cardenas DD, Neishoff EC, Suda K, et al. A randomized trial of pregabalin with neuropathic pain due to spinal cord injury. Neurology. 2013;80(6):533-539. 2. Data on file. Pfizer Inc, New York, NY. 3. Siddall PJ, Cousins MJ, Otte A, Griesing T, Chambers R, Murphy TK. Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. Neurology. 2006;67(10):1792-1800.
*TERMS AND CONDITIONS
Offer Terms & Conditions:
By using the Co-Pay Savings Card, you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions:
Patients are not eligible to use this card or participate in this program if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”). Patient must have private insurance. Offer is not valid for cash paying patients. The value of this card is limited to $175 per month per prescription (“offering period”) or the amount of your co-pay, whichever is less (Maximum annual savings of $2100). This program is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs. You must deduct the value received under this program from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf. You are responsible for reporting use of this program to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the program, as may be required. You should not use the program if your insurer or health plan prohibits use of manufacturer co-pay cards. You must be 18 years of age or older to accept this offer. This offer is not valid where prohibited by law.
For Massachusetts residents:
This co-pay offer is not valid if an A/B generic is available for Massachusetts residents whose prescriptions are covered in whole or in part by third-party insurance.
For California residents:
This co-pay offer is not valid if a generic is available for California residents whose prescriptions are covered in whole or in part by third-party insurance.
Please check with your healthcare professional or insurer to confirm eligibility. This offer cannot be combined with any other savings, free trial or similar offer for the specified prescription. The co-pay card will be accepted only at participating pharmacies. The co-pay card is not health insurance. Offer good only in the U.S. and Puerto Rico. The co-pay card is limited to one per person during this offering period and is not transferable. A co-pay card may not be redeemed more than once per offering period per patient. No other purchase is necessary. Data related to your redemption of the co-pay card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other co-pay card redemptions and will not identify you. Pfizer reserves the right to rescind, revoke or amend this offer without notice. No membership fee. For more information, visit our website www.lyrica.com, call
1-866-954-1475,
or contact us at 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560.
Offer expires 12/31/2020.
For reimbursement when using a nonparticipating pharmacy/mail order:
Pay for prescription, and mail copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount circled to: Co-Pay Savings Card, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560. Be sure to include a copy of the front of your activated Co-Pay Savings Card, your name and mailing address.