Last update 02 May 2024
Purdue Pharma LP
Last update 02 May 2024
Overview
Basic Info
Introduction Purdue Pharma L.P. is a privately-owned pharmaceutical company primarily owned by the descendants of Mortimer and Raymond Sackler. In 2007, the company was fined a record amount for mislabeling its product OxyContin, and three executives were found guilty of criminal charges. Despite shifting its focus to abuse-deterrent formulations, Purdue continued to market and sell opioids, which led to ongoing lawsuits related to the opioid epidemic in the United States. On September 15, 2019, the company filed for Chapter 11 bankruptcy protection in New York. |
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Clinical Outcomes From Injectable Nalmefene in the Emergency Department (COINED)
Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Overactive Bladder Syndrome
Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome
100 Clinical Results associated with Purdue Pharma LP
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01 Nov 2018CNS DrugsQ2 · MEDICINE
From LBR-101 to Fremanezumab for Migraine
Q2 · MEDICINE
Review
Author: Bigal, Marcelo E. ; Rapoport, Alan M. ; Silberstein, Stephen D. ; Walter, Sarah ; Hargreaves, Richard J. ; Aycardi, Ernesto
Calcitonin gene-related peptide (CGRP) is a neuropeptide of importance in migraine pathogenesis. Its central role in migraine was proven pharmacologically by the development of CGRP receptor antagonists. Monoclonal antibodies targeting CGRP or its receptor are effective in the preventive treatment of episodic and chronic migraine and are considered potential breakthroughs in their treatment. Fremanezumab (previously known as TEV-48125, LBR-101, or RN-307) is a humanized IgG2a monoclonal antibody that binds to CGRP. The development of this antibody validated the role of CGRP in chronic migraine and the drug has been recently approved in the US by the FDA, while it continues to be reviewed by other regulatory agencies. Herein we provide an in-depth review of its development. We start by summarizing its in vitro and in vivo pharmacology, and the phase I studies. We then review the late-stage clinical development, with a focus on its efficacy, safety, similarities, and uniqueness relative to other CGRP antibodies. We close by discussing lessons learned on the mechanisms of migraine and areas for future development and exploration.
01 Oct 2016Journal of Clinical PharmacologyQ3 · MEDICINE
Dose-Dependent Flux of Buprenorphine Following Transdermal Administration in Healthy Subjects
Q3 · MEDICINE
Article
Author: Wang, Yi ; Cipriano, Alessandra ; Munera, Catherine ; Harris, Stephen C.
Buprenorphine transdermal delivery system (BTDS) applied once every 7 days is indicated for the management of pain that is severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The 7-day flux of buprenorphine from BTDS to systemic circulation was investigated in a phase 1, 2-period crossover study with 3 randomized groups of healthy subjects receiving BTDS containing buprenorphine 5, 10, or 20 mg for 7 days preceded or followed by intravenous buprenorphine infusion (25 μg/h for 24 hours). Residual and absolute bioavailability methods were used to estimate 7-day flux of buprenorphine. Following BTDS administration, mean area under the curve of buprenorphine increased proportionally (12.6, 24.3, and 51.1 ng/[mL · h]), maximum mean plasma concentration rose with increasing dose (176, 191, and 471 pg/mL), and absolute bioavailability was 14% to 16%. Mean residual amount of buprenorphine in the BTDS after 7-day application was 4.50, 8.57, and 17.1 mg. Flux of buprenorphine was approximately 5, 10, and 20 μg/h for BTDS containing 5, 10, and 20 mg buprenorphine, respectively. BTDS was safe and well tolerated following a single 7-day application in healthy subjects. The results of this study demonstrated dose-dependent flux of buprenorphine delivered via transdermal system.
30 Sep 2016Journal of Pharmacological and Toxicological Methods
Recalibration of nonclinical safety pharmacology assessment to anticipate evolving regulatory expectations
Author: Pugsley, Michael K. ; Authier, Simon ; Hayes, Eric S. ; Hamlin, Robert L. ; Accardi, Michael V. ; Curtis, Michael J.
Safety pharmacol. (SP) has evolved in terms of architecture and content since the inception of the SP Society (SPS). SP was initially focused on the issue of drug-induced QT prolongation, but has now become a broad spectrum discipline with expanding expectations for evaluation of drug adverse effect liability in all organ systems, not merely the narrow consideration of torsades de pointes (TdP) liability testing. An important part of the evolution of SP has been the elaboration of architecture for interrogation of non-clin. models in terms of model development, model validation and model implementation. While SP has been defined by mandatory cardiovascular, central nervous system (CNS) and respiratory system studies ever since the core battery was elaborated, it also involves evaluation of drug effects on other physiol. systems. The current state of SP evolution is the incorporation of emerging new technologies in a wide range of non-clin. drug safety testing models. This will refine the SP process, while potentially expanding the core battery. The continued refinement of automated technologies (e.g., automated patch clamp systems) is enhancing the scope for detection of adverse effect liability (i.e., for more than just IKr blockade), while introducing a potential for speed and accuracy in cardiovascular and CNS SP by providing rapid, high throughput ion channel screening methods for implementation in early drug development. A variety of CNS liability assays, which exploit isolated brain tissue, and in vitro electrophysiol. techniques, have provided an addnl. level of complimentary preclin. safety screens aimed at establishing the seizurogenic potential and risk for memory dysfunction of new chem. entities (NCEs). As with previous editorials that preface the annual themed issue on SP methods published in the Journal of Pharmacol. and Toxicol. Methods (JPTM), we highlight here the content derived from the most recent (2015) SPS meeting held in Prague, Czech Republic. This issue of JPTM continues the tradition of providing a publication summary of articles primarily presented at the SPS meeting with direct bearing on the discipline of SP. Novel method development and refinement in all areas of the discipline are reflected in the content.
27 Mar 2024
100 Deals associated with Purdue Pharma LP
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100 Translational Medicine associated with Purdue Pharma LP
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Pipeline
Pipeline Snapshot as of 20 May 2024
The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3
Preclinical
1
2
Phase 1 Clinical
Phase 2 Clinical
3
6
Approved
Other
37
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