Lyrica CR (pregabalin CR) / Pfizer - LARVOL DELTA

Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets (clinicaltrials.gov) - P=N/A; N=600; Active, not recruiting; Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Neuralgia • Pain • Peripheral Neuropathic Pain

Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets (clinicaltrials.gov) - P=N/A; N=600; Recruiting; Sponsor: Pfizer; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Neuralgia • Pain • Peripheral Neuropathic Pain

[VIRTUAL] Drug utilization evaluation report for the use of gabapentin and pregabalin at CHI Franciscan (ASHP 2020) - "Purpose: Gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) are FDA approved for a variety of conditions, including seizures, nerve pain, and restless legs syndrome...Common opioids were oxycodone, morphine and hydrocodone. Benzodiazepines included diazepam, alprazolam, and clonazepam. Antidepressants noted were mirtazapine, sertraline, escitalopram, and bupropion. Lastly, antipsychotics such as aripiprazole, haloperidol, olanzapine, quetiapine, risperidone, and valproic acid were observed...Benzodiazepine combinations yielded the highest mortality rate of 36%, followed by opioid combinations and cyclobenzaprine, 32% and 30% respectively... Gabapentinoids taken with CNS depressants should be monitored. Patients will be at high risk of developing respiratory depression or increased risk of opioid overdose death. Best safety practices involve initiating gabapentinoids at the lowest dose and providing education to patients to recognize signs and..."

Addiction (Opioid and Alcohol) • Chronic Obstructive Pulmonary Disease • CNS Disorders • Depression • Epilepsy • Immunology • Movement Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain • Psychiatry • Renal Disease • Respiratory Diseases • Restless Legs Syndrome • Sleep Disorder

Efficacy and Safety of the Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and Immediate-release Pregabalin Capsule for Peripheral Neuropathic Pain: a Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial. (PubMed, Clin Ther) - P3 | "GLA5PR GLARS-NF1 tablets can be effectively and safely administered to patients with peripheral neuropathic pain. Furthermore, we found that sleep, anxiety, and depression were improved with pain control. Owing to the once-daily administration, treatment effects can be maximized by improved treatment compliance. ClinicalTrials.gov identifier: NCT03221907."

Clinical • Journal • P3 data • CNS Disorders • Depression • Mood Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain • Psychiatry

Immediate and controlled-release pregabalin for the treatment of epilepsy. (PubMed, Expert Rev Neurother) - "Considering the disappointing results of the only controlled trial, PGB CR is unlikely to become an established epilepsy treatment anytime soon. Nevertheless, given its peculiar properties and potential advantages, PGB (in either formulation) should be further evaluated in specific populations of patients, especially fragile subjects with several comorbidities and complex polytherapies."

Journal • CNS Disorders • Epilepsy • Fibromyalgia • General Anxiety Disorder • Immunology • Mood Disorders • Musculoskeletal Pain • Neuralgia • Pain • Peripheral Neuropathic Pain • Rheumatology

A Open-label, Randomized, Crossover Study to Assess PK of Pregabalin (clinicaltrials.gov) - P1; N=32; Not yet recruiting; Sponsor: Yuhan Corporation

New P1 trial • Biosimilar • Pain

Formulation of a modified-release pregabalin tablet using hot-melt coating with glyceryl behenate. (PubMed) - "The confidence interval of AUC0-24 was within the adequate range, but that of Cmax was inadequate. This study demonstrated the potential use of GB for PRE-containing MR formulations."

Journal • Biosimilar

PK and Food Effect of Pregabalin Study After Dosing in Healthy Male Volunteers (clinicaltrials.gov) - P1; N=64; Active, not recruiting; Sponsor: Yuhan Corporation

New P1 trial • Biosimilar • Gene Therapies • Pain

Pfizer reports first-quarter 2020 results (Pfizer Press Release) - "First-quarter 2020 Upjohn revenues totaled $2.0 billion, down 37% operationally, primarily driven by the expected significant volume declines for Lyrica in the U.S. due to multi-source generic competition that began in July 2019....Xeljanz in international markets, up 38% operationally, primarily reflecting continued uptake in the rheumatoid arthritis indication and, to a lesser extent, from the recent launch of the ulcerative colitis indication in certain developed markets...Xeljanz in the U.S., down 4%, reflecting continued strong demand across all approved indications...Wholesaler inventory levels for Xeljanz were restored to normal levels in early April 2020..."

Commercial • CNS Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Neuralgia • Pain • Psoriasis • Ulcerative Colitis

Development of a Novel Controlled-Release Tablet of Pregabalin: Formulation Variation and Pharmacokinetics in Dogs and Humans. (PubMed, Drug Des Devel Ther) - "The time of the peak plasma concentration at 6 h in the fed state of humans coincided with the results of the study on beagles. The novel TL tablet system of pregabalin may prove to be helpful in developing improved formulations with better continuous drug absorption for OAD administration."

Journal • PK/PD data

Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets (clinicaltrials.gov) - P=N/A; N=600; Active, not recruiting; Sponsor: Pfizer; Not yet recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

"New FDA Drug Safety Communication on gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR): https://t.co/uAGEEeB1yg." (@FDA_Drug_Info)

Clinical

FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) (FDA) - "The U.S. Food and Drug Administration (FDA) is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease (COPD) that reduce lung function. The elderly are also at higher risk."

Adverse events

Pfizer raises profit guidance as Q3 beats views (Market Watch) - "Sales at its Upjohn unit, which includes the cholesterol-controlling Lipitor pills and the pain drug Lyrica, fell 28%, driven by volume declines for Lyrica in the U.S. due to the loss of patent protection."

Commercial

Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets (clinicaltrials.gov) - P; N=600; Not yet recruiting; Sponsor: Pfizer

Clinical • New trial

Customized Novel Design of 3D Printed Pregabalin Tablets for Intra-Gastric Floating and Controlled Release Using Fused Deposition Modeling. (PubMed, Pharmaceutics) - "The optimized formulation (F6) with partially opened top layer showed zero-order drug release. The results show that FDM printing is suitable for the formulation of floating dosage form with the desired drug release profile."

Journal

Comparative Pharmacokinetics of a Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and an Immediate-release Pregabalin Capsule in Healthy Male Volunteers. (PubMed, Clin Ther) - P1; "The overall pregabalin exposure after multiple administrations of GLA5PR GLARS-NF1 tablets was comparable to that after multiple administrations of the IR capsules. A single administration of the GLA5PR GLARS-NF1 tablet produced lower overall pregabalin exposure than that of the same dose administered in 2 IR capsules taken every 12 h. A high-fat diet significantly increased the bioavailability of the GLA5PR GLARS-NF1 tablet. ClinicalTrials.gov identifiers: NCT01638273 and NCT02326987."

Clinical • Journal • PK/PD data

ICER points finger at seven drugs and their price hikes (P&T) - "AbbVie's adalimumab (Humira) and Roche's rituximab (Rituxan) topped a list of seven drugs whose combined 2017 and 2018 price hikes accounted for a $5.1 billion increase in U.S. spending, according to a report released this week by the Institute for Clinical and Economic Review (ICER), the independent cost-effectiveness assessment organization based in Boston....The five other drugs on ICER's list are Pfizer’s pregabalin (Lyrica)...Eli Lilly’s tadalafil (Cialis), and Biogen's dimethyl fumarate (Tecfidera)....The price hikes of the drugs were more than twice the rate of medical inflation and were not supported by any new clinical evidence, according to ICER's analysis."

HEOR

".@drreddys: Gets @US_FDA Tentative Nod For Generic Of Lyrica CR Drug" (@BTVI)

Lyrica not effective for treating traumatic nerve pain - "'While these finding show that pregabalin is not effective in controlling the long-term pain for traumatic injury, it may provide relief for patients (that) experience post-surgical pain,' said lead author John Markman, MD....'Given the rising rates of surgery and shrinking reliance on opioids, it is critical that we understand how to study new drugs that work differently in patients like the ones included in this study,' Markman added."

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