Jun 16: PII/PIII trial (NCT02858726) initiated - phase A will assess the effect of three doses of CR845 vs. placebo, given by IV injection after dialysis sessions and the primary outcome will be intensity of itch after 8 weeks [2]. The primary efficacy endpoint is the proportion of patients achieving at least a 3-point improvement from baseline with respect to the weekly mean of the daily 24-hour worst itching intensity numeric rating scale (NRS) score at week 12. Procardia (nifedipine)." Vifor Fresenius Medical Care Renal Pharma Ltd, May 18: A joint venture of Vifor Pharma Group and Fresenius Medical Care (Vifor Fresenius Medical Care Renal Pharma Ltd [VFMCRP]) acquired an international license to commercialise Korsuva injection outside of the US, Japan and South Korea. Last updated on Jan 25, 2020. Oct 17: following a successful end of PII meeting with the FDA, Cara has established key elements of the pivotal PIII trial programme to support a New Drug Application (NDA) for CR845 for treatment of moderate-to-severe chronic kidney disease-associated pruritus in haemodialysis patients.

Due to its peripheral selectivity, difelikefalin lacks the central side effects like sedation, dysphoria, and hallucinations of previous KOR-acting analgesics such as pentazocine and phenazocine. Jun 17: A 52-week PIII open label extension study (NCT03281538) is currently enrolling up to 240 hemodialysis patients with CKD-associated pruritus who have previously completed one of the company’s PII/III studies [5].

Commonly reported side effects of nifedipine include: dizziness, peripheral edema, lower extremity edema, flushing, and flushing sensation.

[1], 4-amino-1-[(2R)-6-amino-2-[[(2R)-2-[[(2R)-2-[[(2R)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid, CC(C)C[[email protected]](C(=O)N[[email protected]](CCCCN)C(=O)N1CCC(CC1)(C(=O)O)N)NC(=O)[[email protected]@H](CC2=CC=CC=C2)NC(=O)[[email protected]@H](CC3=CC=CC=C3)N, InChI=1S/C36H53N7O6/c1-24(2)21-29(32(45)40-28(15-9-10-18-37)34(47)43-19-16-36(39,17-20-43)35(48)49)42-33(46)30(23-26-13-7-4-8-14-26)41-31(44)27(38)22-25-11-5-3-6-12-25/h3-8,11-14,24,27-30H,9-10,15-23,37-39H2,1-2H3,(H,40,45)(H,41,44)(H,42,46)(H,48,49)/t27-,28-,29-,30-/m1/s1, "A phase 3 trial of difelikefalin in hemodialysis patients with pruritus", Signaling peptide/protein receptor modulators, https://en.wikipedia.org/w/index.php?title=Difelikefalin&oldid=975011980, Chemical pages without DrugBank identifier, Articles containing unverified chemical infoboxes, Creative Commons Attribution-ShareAlike License, This page was last edited on 26 August 2020, at 06:42. [1][3][4][5] It is under development by Cara Therapeutics as an intravenous agent for the treatment of postoperative pain. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Jun 17: FDA assigns Breakthrough Therapy Designation to CR845 for treatment of uraemic pruritus, based on data from Part A of PII/III NCT02858726 study which reported 68% relative reduction in worst itching scores vs. placebo after 8 weeks [3]. You may report them to the FDA.

[1] Activation of KORs on peripheral nerve terminals results in the inhibition of ion channels responsible for afferent nerve activity, causing reduced transmission of pain signals, while activation of KORs expressed by immune system cells results in reduced release of proinflammatory, nerve-sensitizing mediators (e.g., prostaglandins). Uraemic pruritus develops in upwards of 60-70% of dialysis patients [1]. See below for a comprehensive list of adverse effects.

2 Names and Identifiers Expand this section. Cara expects to initiate the PIII programme by the end of 2017 [6].

Aug 18: A second PIII trial of difelikefalin injection for treatment of moderate-to-severe CKD-aP in haemodialysis patients (KALM-2) starts (NCT03636269). We comply with the HONcode standard for trustworthy health information -, Drug class: calcium channel blocking agents, fast, irregular, pounding, or racing heartbeat or pulse, shakiness in the legs, arms, hands, or feet, trembling or shaking of the hands or feet, coughing that sometimes produces a pink frothy sputum, difficult, fast, or noisy breathing, sometimes with wheezing, pain or discomfort in the arms, jaw, back, or neck, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, increased urge to urinate during the night, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope, sores, ulcers, or white spots on the lips or in the mouth, unsteadiness, trembling, or other problems with muscle control or coordination, vomiting of blood or material that looks like coffee grounds, redness of the face, neck, arms, and occasionally, upper chest, difficulty having a bowel movement (stool), excess air or gas in stomach or intestines, feeling of constant movement of self or surroundings, loss in sexual ability, desire, drive, or performance, increased sensitivity of the skin to sunlight, itching, pain, redness, swelling, tenderness, or warmth on the skin, redness or other discoloration of the skin, swelling of the breasts or breast soreness in both females and males.

Aug 18: A second PIII trial of difelikefalin injection for treatment of moderate-to-severe CKD-aP in haemodialysis patients (KALM-2) starts (NCT03636269). In Addition To Use As An Analgesic, Difelikefalin Is Also Being Investigated For The Treatment Of Pruritus (Itching).

In the UK in 2013/14, there were 4.7 million surgical admissions [11].

Other side effects include:acute myocardial infarction, muscle cramps, tremor, cough, dyspnea, hypotension, and wheezing. Results from the trial will be used to support a NDA [7]. [3][5] It has also completed a phase III clinical trial for uremic pruritus in hemodialysis patients. Bayer, West Haven, CT. 2.

Other side effects include: acute myocardial infarction, muscle cramps, tremor, cough, dyspnea, hypotension, and wheezing. [1][3] In addition to use as an analgesic, difelikefalin is also being investigated for the treatment of pruritus (itching). It is a severe itch associated with a 17% increase in mortality in haemodialysis patients [4]. DrugBank. Adalat (nifedipine)." The 12-week trial, with a 52-week open label extension phase, is enrolling approximately 350 patients in the US. Although not all of these side effects may occur, if they do occur they may need medical attention. May 18: PIII KALM-1 study is recruiting and expects to complete collection of primary outcome data in Feb 19 [8]. Pfizer US Pharmaceuticals, New York, NY. Medically reviewed by Drugs.com. O 0.

[5] Due to its peripheral selectivity, difelikefalin lacks the central side effects like sedation, dysphoria, and hallucinations of previous KOR-acting analgesics such as pentazocine and phenazocine. RMOC materials on adalimumab are below under medicines, Our resource hub supports pharmacy teams in care homes who are responding to increased pressure during the COVID-19 pandemic. Primary outcome data collection is expected to be completed in Dec 19 [9,10]. [8], A peptidergic, long-acting κ opioid receptor agonist. Applies to nifedipine: oral capsule liquid filled, oral tablet extended release. 4 Related Records Expand this section. Cerner Multum, Inc. "Australian Product Information." In addition to use as an analgesic, difelikefalin is also being investigated for the treatment of pruritus (itching). Use gov.uk for the government response, and nhs.uk for health information.

A peptidergic, long-acting κ opioid receptor agonist which is designed to have reduced side-effects as compared with traditional µ opioid receptor agonists such as morphine. Available for Android and iOS devices. If you need to know more you can ask one of our experts for help. Commonly reported side effects of nifedipine include: dizziness, peripheral edema, lower extremity edema, flushing, and flushing sensation. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Find all our resources on COVID-19 here and filter by your area of interest. [1][3][5] An oral formulation has also been developed. [6], Difelikefalin acts as an analgesic by activating KORs on peripheral nerve terminals and KORs expressed by certain immune system cells. The primary efficacy endpoint is the proportion of patients achieving at least a 3-point improvement from baseline with respect to the weekly mean of the daily 24-hour worst itching intensity NRS score at week 12. 4.

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