Purdue Pharma

About: Purdue Pharma is a company organization based out in Pickering, Ontario, Canada. It is known for research contribution in the topics: Buprenorphine & Chronic pain. The organization has 622 authors who have published 691 publications receiving 31545 citations. The organization is also known as: Purdue Pharmaceuticals L.P..

Correcting Naldemedine (Symproic) Product Summary.

Abstract: To the Editor: As the marketer and distributor of naldemedine (Symproic®) tablets, Purdue Pharma L.P. strives to ensure that the information about Symproic in published resources is accurate. The article published in the August 2017 issue of P&T entitled “Pharmaceutical Approval Update” by Michele B. Kaufman, PharmD, BCGP, RPh, includes a review of naldemedine (Symproic).1 The following information in this article requires further clarification and corrections:

Once-daily oral ir/cr pramipexole formulation

Abstract: An oral once-daily pramipexole formulation, comprising an immediate-release component and a controlled-release component, is provided wherein in preferred embodiments, both the immediate-release component and the controlled-release component comprise pramipexole The formulation is preferably in the form of a coated bead A method of manufacturing said formulation is also provided.

Comment and Reply on:Randomized trial comparing polymer-coated extended-release morphine sulfate to controlled-release oxycodone HCl in moderate to severe nonmalignant pain

Abstract: We are writing in response to the study entitled ‘Randomized trial comparing polymer-coated extended-release morphine sulfate to controlled-release oxycodone HCl in moderate to severe nonmalignant pain’, published in the August 2006 issue of Current Medical Research and Opinion by Nicholson et al.. We agree with the authors that for patients with chronic pain, opioids should be administered around-theclock to achieve continuous pain relief, and modifiedrelease dosage forms of morphine and oxycodone provide additional options to appropriate patients with moderate to severe chronic pain. The stated purpose of this study was ‘to compare the efficacy, tolerability and safety’ of polymer-coated extended-release morphine sulfate (P-ERMS; Kadian*) to that of controlledrelease oxycodone HCl (CRO; OxyContin†) ‘in the long-term treatment of chronic, moderate to severe, nonmalignant pain in a community-based outpatient population’. While we commend the stated aim of the study, the method of the study and conclusions lead to concerning and misleading inferences regarding the dosing and administration of CRO Tablets. First, we would like to address this statement in the ‘Introduction’ section: ‘Clinicians have reported that effective pain relief with CRO may require dosing three times daily (TID) or even four times daily (QID) ’. The three references cited in support of this statement are not well-controlled clinical studies evaluating the safety and efficacy of dosing CRO more frequently than q12h, but rather are two retrospective chart reviews and a patient-reported utilization survey. These reviews and survey did not evaluate patients’ pain control or tolerability of the medication with more frequent dosing schedules and therefore, from a safety and efficacy standpoint, are not adequate references to support CRO dosing at less than q12h intervals. Next, we would like to comment on the titration protocol presented in Figure 1 of the ‘Study design/ methodology’ section. We are perplexed with the rationale for the titration design where ‘after Weeks 2, 4, 8 and 12 clinicians were allowed to up-titrate the dose of study medication (if not increased during the previous visits) or to switch to BID dosing of P-ERMS or TID dosing of CRO (if the dose was increased at the previous visit). After Week 12, if necessary, the clinician could adjust the patient’s dosing as clinically indicated during the interim.’ While it is not clear what is meant by ‘the clinician could adjust the patient’s dosing as clinically indicated’, the titration scheme to increase the CRO dosing frequency is not consistent with the recommended dosing for CRO. As stated in the prescribing information for CRO, it is most appropriate to increase the q12h dose, not the dosing frequency. There are no well-controlled clinical studies on dosing intervals shorter than q12h. The efficacy and safety of CRO q12h has been well substantiated by numerous controlled clinical trials in various chronic pain states.

Formula (IA″) compounds comprising (piperidin-4-yl)pyridine or (1,2,3,6-tetrahydropyridin-4-4yl) as TRPV1 antagonists

Abstract: The invention relates to compounds of formula IA″ and pharmaceutically acceptable derivatives thereof, compositions comprising an effective amount of a compound of formula IA″ or a pharmaceutically acceptable derivative thereof, and methods for treating or preventing a condition such as pain, UI, an ulcer, IBD and IBS, comprising administering to an animal in need thereof an effective amount of a compound of formula IA″ or a pharmaceutically acceptable derivative thereof.

Transdermal patch with plural on-board energy storage devices

Abstract: A transdermal patch can include a drug source, a porator, and an energy storage device on-board the patch. Conductive contact terminals can extend from the energy storage device for connection to an external source of power. The porator operates free of any concurrent connection to any external source of power. A switch can be used to make the selective electrical connection between the porator and the energy storage device. The switch can be arranged to respond to a manual user action after the patch has been adhered to skin, including separation of the porator from a remainder of the patch. Optionally, a series of switches can make electrical connections between the porator and respective individual energy storage devices. In another aspect, a transdermal patch includes a mechanical bias that applies a displacement force to the porator to thereby better ensure good physical contact between the porator and the skin.