LYRICA^® reduces excessive release of excitatory neurotransmitters¹

LYRICA^® selectively binds with high affinity to the α2-δ subunit of voltage-gated calcium channels found throughout the nervous system, attenuating calcium influx.^1,2

Overactive neurotransmission of neurons releasing substance P, glutamate, and norepinephrine is restored to its normal physiologic state.¹

LYRICA^® provides rapid, sustained pain relief from peripheral neuropathic pain^1,2

LYRICA^® provides rapid, sustained pain relief from peripheral neuropathic pain^1,2

Improvement in pain scores for pDPN

LYRICA^® 300 mg/day and 600 mg/day significantly improved pain vs placebo as early as week 1 onward, for the duration of the 5-week study.³

LOCF = Last observation carried forward

*A 5-week, randomized, double-blind, placebo-controlled study of LYRICA^® (pregabalin) in the treatment of painful diabetic peripheral neuropathy (DPN) (study 029/study DPN 1 in USPI). Patients were randomized to, and treated with, LYRICA^® 75 mg/day (n=77), 300 mg/day (n=81), 600 mg/day (n=82) or placebo (n=97), taken in a TID (three times daily) dosing schedule. Patients in the 75 and 300 mg/day groups received their full randomized dose from the start of the study. The patient numbers shown on the slide refer to the number of patients included in the primary intention to treat (ITT), last observation carried forward (LOCF) analysis at end point. Changes over time are based on observed case analysis (OC). The primary efficacy variable was, as for all pain studies, the mean end point pain score in each LYRICA^® group compared with placebo, based on pain scores from the last 7 days’ diary entries while patients were on treatment. The mean weekly scores were also compared.³

LYRICA^® 600 mg/day was significantly more effective in improving pain than placebo from week 2, and for the duration of the 6-week study⁴

LOCF = Last observation carried forward

*A 6-week, randomized, double-blind, placebo-controlled study of LYRICA^® (pregabalin) in the treatment of painful diabetic peripheral neuropathy (DPN) (study 014). Patients were randomized to, and treated with, LYRICA^® 150 mg/day (n=79), 600 mg/day (n=82) or placebo (n=85), taken in a TID (three times daily) dosing schedule. The patient numbers shown on the slide refer to the number of patients included in the primary intention to treat (ITT), last observation carried forward (LOCF) analysis at end point. Changes over time are based on observed case analysis (OC). The primary efficacy variable was, as for all pain studies, the mean end point pain score in each LYRICA^® group compared with placebo, based on pain scores from the last 7 days’ diary entries while patients were on treatment. The mean weekly scores were also compared.⁴

pDPN efficacy: Patient global impression of change (PGIC)

LYRICA^® 300 mg/day and 600 mg/day significantly improved patients’ impression of pain³

*A 5-week, randomized, double-blind, placebo-controlled study of LYRICA^® (pregabalin) in the treatment of painful diabetic peripheral neuropathy (DPN) (study 029/study DPN 1 in USPI). Patients were randomized to, and treated with, LYRICA^® 75 mg/day (n=77), 300 mg/day (n=81), 600 mg/day (n=82) or placebo (n=97), taken in a TID (three times daily) dosing schedule. Patients in the 75 and 300 mg/day groups received their full randomized dose from the start of the study. The patient numbers shown on the slide refer to the number of patients included in the primary intention to treat (ITT), last observation carried forward (LOCF) analysis at end point. Changes over time are based on observed case analysis (OC). The primary efficacy variable was, as for all pain studies, the mean end point pain score in each LYRICA^® group compared with placebo, based on pain scores from the last 7 days’ diary entries while patients were on treatment. The mean weekly scores were also compared.³

Significant improvement in sleep for pDPN patients at all three licensed doses

The improvement in pain-related sleep interference from baseline to endpoint was significantly greater with LYRICA^® 150, 300 and 600 mg/day than placebo.⁶

An improvement in sleep quality was observed as early as week 1.⁵

LYRICA^® safety & tolerability

LYRICA^® offers flexible dosing based on individual response and tolerability¹

Dizziness and somnolence are the most common adverse events and are mild to moderate and usually transient²; discontinuation rates due to the most common adverse events are low.³

In a pooled analysis of seven double-blind, randomised, placebo-controlled trials using LYRICA^® to treat painful DPN, adverse events were generally mild to moderate.³

The majority of patients with painful DPN are satisfied with the tolerability of LYRICA^®.4

Based on data from a pooled analysis of seven controlled trials of patients with painful DPN. Common treatment-emergent adverse events and discontinuations occurring in ≥5% of any treatment group. One patient in the 600 mg group had both oedema and peripheral oedema.³

LYRICA^® offers flexible dosing according to patients’ response to treatment and tolerability¹

Flexible dosing allowing BID or TID¹ may be taken with or without food.¹

A predictable dose response² due to its linear pharmacokinetics^1,2, efficacy increases with increasing dose (based on data in painful DPN).³

Start with a low dose¹

Initiate with 150 mg per day given as 2 or 3 divided doses

Gradually increase dose (if necessary)

Increase your patients’ dose based on your careful evaluation of their response and tolerability and without exceeding the maximum recommended dose

For neuropathic pain¹:

•  After 3 to 7 days: Increase to 300 mg per day
• After an additional 7 days: Increase to a maximum of 600 mg per day

LYRICA^® main clinical information in peripheral neuropathic pain

LYRICA^® clinical information on its efficacy, including Improvement in pain scores for Diabetic Peripheral Neuropathy (pDPN), Patient global impression and improvement in sleep for (pDPN) patients^1-7

LYRICA^® provides fast onset and sustained relief in fibromyalgia patients^1,2

LYRICA^® provides fast onset and sustained relief in fibromyalgia patients^1,2

Improvements in pain were observed across all doses of LYRICA^®, as early as 1 week, and sustained to 14 weeks.³

Results from a 13-week study demonstrated significant improvement at end point in mean pain score across all doses of LYRICA^® vs placebo (P<0.05).¹

Baseline mean = 6.7 (moderate to severe pain)³

P values based LS means using MMRM (mixed model repeated measures) ANCOVA. Scored 0-10, lower score represents improvement³

LYRICA^® provides long-term improvement across pain, sleep, fatigue, anxiety and functioning^1,4

Improvements in sleep quality were observed as early as 1 week, with all doses of LYRICA^®.3

Results from a 13-week study similarly demonstrated significant improvement in sleep quality across the 3 doses of LYRICA^® vs placebo (P≤0.001).¹

Improvements were sustained to 14 weeks.³

Baseline mean = 6.23

P values based LS means using MMRM ANCOVA. Scored 0-10, lower score represents improvement³

LYRICA^® improves global well-being in fibromyalgia patients¹

More than 70% of LYRICA^® patients reported improvement in their condition.¹

Adapted from Mease PJ, Russell IJ, Florian H, et al. A randomized, double-blind, placebo-controlled, phase III trial of LYRICA^® In the treatment of patients with fibromyalgia. J Rheumatol. 2008;35(3):502-514. Change in Patient Global Impression of Change scores in a randomized, controlled trial of LYRICA^® 300 mg/day (n=185), 450 mg/day (n=183), or 600 mg/day (n=190) vs placebo (n=190) in patients with fibromyalgia. The scores reflect patients’ assessment of their own improvement, considering their pain, as well as their physical and emotional functioning and the impact of adverse events^.1

LYRICA^® safety & tolerability

LYRICA^® offers flexible dosing based on individual response and tolerability¹

Dizziness and somnolence are the most common adverse events and are mild to moderate and usually transient;² discontinuation rates due to the most common adverse events are low.³

LYRICA^® offers flexible dosing based on individual response and tolerability¹

• Flexible dosing allowing BID may be taken with or without food¹

• A predictable dose response² due to its linear pharmacokinetics^1,2 efficacy increases with increasing dose³

Start with a low dose

Initiate with 150 mg per day given as 2 or 3 divided doses¹

For Fibromyalgia¹:

The recommended dose of pregabalin is 300 to 450 mg per day. Dosing should begin at 75 mg two times a day (150 mg per day) and may be increased to 150 mg two times a day (300 mg per day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg per day may be further increased to 225 mg two times a day (450 mg per day).

Note: Please refer to the full prescribing information before prescribing

LYRICA^®

Content: Pregabalin. Indications: Treatment of neuropathic pain, including diabetic peripheral neuropathy and post-herpetic neuralgia in adults; generalized anxiety disorder (GAD) in adults. Adjunctive therapy of partial seizures with or without secondary generalization in adults. Management of fibromyalgia. Dosage: Neuropathic pain Initially 150 mg/day, may be increased to 300 mg/day after an interval of 3-7 days. Max: 600 mg/day after an additional 7-day interval. Epilepsy Initially 150 mg/day, may be increased to 300 mg/day after 1 week. Max: 600 mg/day after an additional week. GAD 150-600 mg/day given in 2 or 3 divided doses. Initially 150 mg/day, may be increased to 300 mg/day after 1 week. Following an additional week, dose may be increased to 450 mg/day. Max: 600 mg/day after an additional week. Fibromyalgia Recommended dose: 300-450 mg/day. Initially 75 mg twice a day, may be increased within 1 week to 150 mg twice a day. Max: 450 mg/day. Administration: May be taken with or without food. Contraindications: Hypersensitivity. Special Precautions: Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Discontinue treatment if symptoms of angioedema (eg facial, perioral or upper airway swelling) occur or if myopathy is diagnosed or suspected, or if markedly elevated creatinine kinase levels occur. Patients with diabetes or severe congestive heart failure. Association with serious, life-threatening, or fatal respiratory depression when co-administered with CNS depressants, including opioids, or in the setting of underlying respiratory impairment. Monitor symptoms following discontinuation of therapy. Carefully evaluate patients for history of drug abuse and observe for signs of pregabalin misuse or abuse (eg development of tolerance, dose escalation, drug-seeking behavior). Monitor patients for signs of suicidal ideation and behavior. May affect ability to drive or operate machinery. Pregnancy and lactation. Children less than 12 years and adolescents. Elderly more than 65 years. Adverse Drug Reactions: Dizziness, somnolence; nasopharyngitis; increased appetite; euphoric mood, confusion, irritability, depression, disorientation; insomnia, decreased libido; ataxia, abnormal coordination, tremor, dysarthria, amnesia, memory impairment, attention disturbance, paraesthesia, hypoesthesia, sedation, balance disorder, lethargy; blurred vision, diplopia; vertigo; vomiting, constipation, flatulence, abdominal distension, dry mouth; muscle cramp, arthralgia, back pain, pain in limb, cervical spasm; peripheral oedema, oedema, abnormal gait, fall, feeling of drunkenness; abnormal feeling, fatigue; increased weight. Headache; nausea, diarrhea. Seizures were also reported in post-marketing surveillance when pregabalin was taken in overdose. Drug Interactions: May potentiate the effects of ethanol and lorazepam. Additive in the cognitive and gross motor function impairment caused by oxycodone. Potential risk of respiratory failure, coma and death with other central nervous system depressants (including in substance abuse); reduced lower gastrointestinal tract function (eg intestinal obstruction, paralytic ileus, constipation) with opioid analgesics. Increased risk of CNS depression when concomitantly prescribed with CNS depressants, including opioids. Product Presentation: Cap 25 mg x 56's. Cap 50 mg x 56's. Cap 75 mg x 56's. Cap 100 mg x 56's. Cap 150 mg x 56's. API-LYR-SIN-0420/1 | Full prescribing information is available upon request.