Delving into the Latest Updates on Naldemedine Tosylate with Synapse

Opioid-induced bowel dysfunction is a frequent condition during opioid therapy for chronic pain. Indeed, up to 90% of people on opioid treated patients experience constipation. Standard laxative treatment is often ineffective in opioid-induced constipation, but peripheral acting mu-receptor antagonists (PAMORAs) have the potential to block the effects of opioids in the gastrointestinal tract while preserving the central analgesic effect. In this study, we will investigated the effects of Naldemedine in preventing the development of opioid-induced bowel dysfunction and constipation during treatment with tramadol

Start Date12 Mar 2024

Sponsor / Collaborator

Aalborg University Hospital

NCT05588323 / RecruitingPhase 1/2

A Phase 1/2, Multicentre, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Naldemedine in Paediatric Patients Who Are Receiving or Who Are About to Receive Treatment With Opioids

The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.

Start Date04 Jan 2023

Sponsor / Collaborator

Shionogi, Inc.

CTR20220673 / RecruitingPhase 3

一项Naldemedine 治疗癌痛患者合并阿片类药物引起的便秘的多中心、包含安慰剂对照治疗期与开放治疗期两阶段的研究

[Translation] A multicenter, placebo-controlled, open-label study of naldemedine in the treatment of cancer pain patients with opioid-induced constipation

主要目的：评价与安慰剂相比Naldemedine治疗2周的疗效。主要疗效终点为14天治疗期间自发排便（SBM）应答者的比例。SBM应答者定义为受试者每周SBM≥ 3次且较基线期增加≥1次SBM/周。

[Translation]

Primary objective: To evaluate the efficacy of naldemedine compared with placebo for 2 weeks. The primary efficacy endpoint was the proportion of spontaneous bowel movement (SBM) responders during the 14-day treatment period. SBM responders were defined as subjects with ≥ 3 SBMs per week and an increase of ≥ 1 SBM/week from baseline.

Start Date15 Jul 2022

Sponsor / Collaborator

Ping An Shionogi Co., Ltd.

100 Clinical Results associated with Naldemedine Tosylate

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100 Translational Medicine associated with Naldemedine Tosylate

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100 Patents (Medical) associated with Naldemedine Tosylate

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117

Literatures (Medical) associated with Naldemedine Tosylate

01 Apr 2024·Journal of pain and symptom management

The Management of Opioid-Induced Constipation in Cancer and Advanced Illness: A Meta-Analysis

Review

Author: Abubakar, Aminu Kende ; Kowe, Temitope ; Latuga, Natalie ; Abioye, Ajibola Ibraheem ; Omotayo, Moshood Olanrewaju ; Ogunlade, Samuel ; Jesuyajolu, Damilola Alexander ; Tangeman, John

CONTEXT:

Constipation is a common problem among patients with cancer. By some accounts, about 60% of cancer patients experience constipation. There is limited empirical evidence of the clinical effectiveness of pharmacologic agents in opioid-induced constipation in advanced diseases.

OBJECTIVES:

We sought to quantitatively summarize the therapeutic effectiveness of the pharmacologic means of managing opioid-induced constipation.

METHODS:

Randomized control trials (RCTs) identified from medical literature databases that reported quantitative measures of the effect of pharmacotherapeutic agents to treat opioid induced constipation in patients with cancers and other advanced illnesses were included in this study. A conventional random effects meta-analysis was conducted including >3 trials with the same exposure and outcome assessed, and a network-meta-analysis was conducted for all placebo-controlled trials.

RESULTS:

Eighteen studies that examined the effect of various pharmacotherapeutic agents were included. The medications were Methylnatrexone (N = 5), Naldemedine (N = 5), other conventional agents (N = 4) and herbal medicines (N = 4). In conventional meta-analysis, methylnaltrexone increased the proportion achieving rescue-free laxation by 2.68 fold (95% CI: 1.34, 5.37; P = 0.0054) within 4 hours of the administration compared to placebo. In network meta-analysis, the pooled RR of the pharmacotherapeutic agents on rescue-free bowel movements as 2.26 (95% CI: 1.52, 3.36) for methylnaltrexone, 1.58 (95% CI: 0.94, 2.66) for naldemedine, and 0.74 (95% CI: 0.45, 1.23) for polyethylene glycol, compared to placebo.

CONCLUSION:

Methylnatrexone and Naldemedine have currently shown promise in randomized trials concerning opioid-induced constipation in cancer and advanced illness. It is imperative that future research ascertain not just the relative therapeutic efficacy but also the cost-benefit analyses of these newer regimens with more commonly used and accessible laxatives.

01 Dec 2023·BMJ supportive & palliative care

Naldemedine-laxative combination: retrospective inpatient study

Article

Author: Takemura, Miho ; Niki, Kazuyuki ; Miyaguchi, Sho ; Ueda, Mikiko

Objectives:

The initiation of peripherally acting μ-opioid receptor antagonists (PAMORAs) should be considered 2 weeks after conventional laxatives have failed to achieve an adequate response, and affected patients should be evaluated every 2 weeks thereafter. However, this guidance is difficult to implement in acute care hospitals. This study aimed to examine how naldemedine (PAMORA) should be introduced in combination with other laxatives in the acute care setting.

Methods:

This retrospective study evaluated 93 inpatients who received at least four doses of naldemedine. We investigated changes in the average daily defecation counts during the first 7 days after compared with before naldemedine administration and the incidence of diarrhoea.

Results:

Daily defecation counts during the first 7 days after compared with before naldemedine administration were greater in both the naldemedine, magnesium oxide (MgO) and another laxative group, and in the naldemedine and another laxative other than MgO group than in the naldemedine only group. The incidence rates of diarrhoea were significantly higher in the naldemedine, MgO, and another laxative group, and in the naldemedine and another laxative other than MgO group than in the naldemedine only group.

Conclusions:

The introduction of naldemedine alone or in combination with MgO should be considered.

01 Dec 2023·BMJ supportive & palliative care

Naldemedine versus placebo in opioid-induced constipation: a meta-analysis

Article

Author: Wobbe, Bastian ; Köhne, Claus-Henning ; Gerner, Maximilian

Objective:

Opioid-induced constipation (OIC) is a frequent adverse event among patients receiving chronic pain therapy that is requiring opioids. Naldemedine was approved by the Food and Drug Administration to treat OIC and appears to be more efficient than any other peripherally acting µ-opioid receptor antagonist. This meta-analysis aimed at assessing the available data on naldemedine in terms of efficacy.

Methods:

We searched the Cochrane Library, PubMed and ClinicalTrials on 24 May 2022 to identify randomised controlled trials (RCTs) comparing naldemedine to placebo among patients reporting OIC.

Results:

Evaluation of 6 RCTs enrolling 2769 participants showed significantly greater respondence to treatment (OR=2.48; 95% CI: 2.02 to 3.06; p<0.00001), change in weekly spontaneous bowel movements (SBMs) (mean difference=1.45; 95% CI: 1.14 to 1.76; p<0.00001), complete SBMs (mean difference=0.89; 95% CI: 0.62 to 1.17; p<0.00001) and SBMs without straining (mean difference=0.89; 95% CI: 0.61 to 1.17; p<0.00001) for patients treated with naldemedine. We found no difference in numeric pain rating scales after one (mean difference=0.05; 95% CI: −0.22 to 0.31; p=0.73) and two weeks of treatment (mean difference= −0.04; 95% CI: −0.31 to 0.22; p=0.75). Funding and clinical diversity were possible risks of bias.

Conclusions:

Naldemedine improves a variety of bowel function parameters while preserving analgesia, confirming its efficacy for patients with OIC. However, head-to-head trials are needed to establish naldemedine as treatment of first choice for laxative-refractory OIC.

PROSPERO registration number:

CRD42022281353.

1

News (Medical) associated with Naldemedine Tosylate

07 May 2021

·www.biospace.com

BioDelivery Sciences Reports First Quarter 2021 Results

Total Company Net Revenue of $41 Million, an Increase of 7% versus Prior Year Net Income of $5.2 Million, EBITDA Margin of 22% and Operating Cash Generation of $11 Million Conference Call and Webcast Scheduled for 8:30 AM EST Today RALEIGH, N.C., May 06, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International (NASDAQ: BDSI), a growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today reported strong financial results for the first quarter ended March 31, 2021, including the following operational and performance highlights. Key Business Highlights Total Company net revenue for the first quarter increased by 7% versus the prior year period to $41.0 million. This growth was driven by BELBUCA® net sales of $36.4 million, which increased 9%, and Symproic® net sales of $4.4 million, which increased 5%. BELBUCA continued to deliver an all-time high quarterly market share, despite pandemic challenges and the impact of winter storm Uri. Total BELBUCA prescriptions were approximately 113,000 during the first quarter, representing year-over-year prescription volume growth of 9%. Total Symproic prescriptions were approximately 17,000 in the first quarter, consistent with prescriptions for the prior year period. Continued to achieve strong profitability, delivering $5.2 million of GAAP Net Income and an attractive 22% EBITDA margin in the first quarter of 2021. The Company repurchased 1.6 million shares in the quarter under its share buyback program, at an average price of $3.87 per share. “We again delivered solid top and bottom-line growth in a challenging quarter against the backdrop of the pandemic and weather-related disruptions, resulting in 22% EBITDA margin and $11 million operating cash flow generation,” stated Jeff Bailey, CEO of BDSI. “Our performance highlights the strength of our commercial team and the persistent market demand for our highly differentiated products. We expect continued success as the selling environment improves throughout the year, including increases of in-office patient visits and more face-to-face interactions with health care providers by our sales representatives.” First Quarter 2021 Financial Results Total Company Net Revenue for the first quarter of 2021 was $41.0 million, an increase of 7% compared to $38.3 million in the first quarter of 2020. Total product net revenue, including sales of BELBUCA and Symproic, grew 8% year over year. Severe winter weather conditions, especially in the South-Central region where the Company has strong market presence, affected patients’ access to their physicians and pharmacies. Additionally, the severe weather delayed shipments of the Company’s products to pharmacy distribution centers of the major wholesalers. BELBUCA Net Sales for the first quarter of 2021 were $36.4 million, an increase of 9% compared to $33.5 million in the first quarter of 2020. As we typically experience each year, BELBUCA gross to net deductions were lower in the first quarter, largely due to the Medicare coverage gap impact. Symproic Net Sales for the first quarter were $4.4 million, an increase of 5% compared to $4.2 million in the first quarter of 2020. Symproic net sales benefited from reduced gross to net deductions in the first quarter due to the typical decreases seen for Medicare coverage gap, as well as updates to our gross to net deductions related to channel estimates. Total Operating Expenses for the first quarter of 2021 were $27.8 million, compared to $26.7 million in the first quarter of 2020. The increase in spending as compared to fourth quarter of 2020 was driven by increased investments in sales and marketing and $3.0 million higher legal spend in the quarter, primarily due to costs associated with the Paragraph IV patent litigation. GAAP Net Income for the first quarter of 2021 was $5.2 million, or $0.05 per share, compared to GAAP net income of $5.0 million, or $0.05 per share, in the first quarter of 2020. EBITDA for the first quarter of 2021 was $9.2 million, or 22% of net sales, compared to $7.8 million or 20% of net sales, in the first quarter of 2020. Non-GAAP Net Income for the first quarter of 2021 was $8.5 million and reflects GAAP net income excluding stock-based compensation and non-cash amortization of intangible assets as compared to non-GAAP net income of $8.3 million in the first quarter of 2020, excluding the same items Cash Position: As of March 31, 2021, cash and cash equivalents were approximately $116.4 million, compared to $111.6 million as of December 31, 2020. The total cash flow generation over the quarter of $4.9 million includes continued strong operating cash generation of $11.1 million, partially offset by $6.1 million used to repurchase shares in the quarter. Financial Guidance The Company reiterates its 2021 financial guidance, with full year 2021 total Company net sales of $170 - $180 million, including full year 2021 BELBUCA net sales of $155 - $165 million. Total operating expenses are expected to be in the range of $115 - $120 million, as the Company continues to invest to support the growth of its brands, and EBITDA is expected to be in the range of $40 - $50 million in 2021. The Company expects to continue delivering positive operating cash flow throughout 2021. “Our confidence in the continued growth of our brands and the profitability of our business remains unchanged. This is demonstrated by our continuing investments behind our portfolio, together with the share repurchase program which is underway. We remain on track to drive long-term shareholder value, and are actively considering potential business development opportunities,” stated Jeff Bailey. Conference Call & Webcast Details BioDelivery Sciences will host a conference call and webcast today, May 6, 2021, at 8:30 a.m. ET to present first quarter 2021 results and to provide a business update. Dial-in details are as follows: ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC. BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions. BDSI has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs. BDSI's marketed products address serious and debilitating conditions, including chronic pain and opioid-induced constipation. CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS This press release and any statements of employees, representatives, and partners of BioDelivery Sciences International, Inc. (“BDSI”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to BDSI’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of BDSI’s management and are subject to significant risks and uncertainties, including those detailed in BDSI’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, the expectations for total company net sales, BELBUCA net sales, operating expenses, EBITDA and operating cash flows in 2021) may differ materially from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond BDSI’s control) including the risk that the current coronavirus pandemic impacts on our supply chain, commercial partners, patients and their physicians and the healthcare facilities in which they work, and our personnel are greater than we anticipate, as well as those set forth in our 2020 annual report on Form 10-K filed with the US Securities and Exchange Commission and subsequent filings. BDSI undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law. Non-GAAP Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the United States, or GAAP, including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. Non-GAAP net income adjusts for one-time and non-cash charges by excluding the following from GAAP net income: stock-based compensation expense and non-cash amortization of intangible assets. EBITDA excludes net interest, including both interest expenses and interest income, provision for (benefit from) income taxes, depreciation, and amortization. The Company's management and board of directors utilize these non-GAAP financial measures to evaluate the Company's performance. The Company provides these non-GAAP measures of the Company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the Company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of our liquidity. A reconciliation of certain GAAP to non-GAAP financial measures has been provided in the tables included in this press release. © 2021 BioDelivery Sciences International, Inc. All rights reserved. Contact: Bob Yedid LifeSci Advisors 646-597-6989 Bob@LifeSciAdvisors.com BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS) (Unaudited) BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS) (Unaudited) BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (U.S. DOLLARS, IN THOUSANDS) (Unaudited) BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES RECONCILIATION OF NON-GAAP METRICS (U.S. DOLLARS, IN THOUSANDS) (Unaudited)

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100 Deals associated with Naldemedine Tosylate

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KEGG	Wiki	ATC	Drug Bank
-	Naldemedine Tosylate	A06AH05	DB11691

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Opioid-Induced Constipation	US	BioDelivery Sciences International, Inc.	23 Mar 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cancer Pain	Phase 3	CN	Ping An Shionogi Co., Ltd.	15 Jul 2022
Constipation	Phase 3	CN	Ping An Shionogi Co., Ltd.	15 Jul 2022
Chronic Pain	Phase 3	US	Shionogi, Inc.	29 Aug 2013
Chronic Pain	Phase 3	AT	Shionogi, Inc.	29 Aug 2013
Chronic Pain	Phase 3	CZ	Shionogi, Inc.	29 Aug 2013
Chronic Pain	Phase 3	DE	Shionogi, Inc.	29 Aug 2013
Chronic Pain	Phase 3	PL	Shionogi, Inc.	29 Aug 2013
Chronic Pain	Phase 3	ES	Shionogi, Inc.	29 Aug 2013
Chronic Pain	Phase 3	GB	Shionogi, Inc.	29 Aug 2013
Gastrointestinal dysfunction	Phase 2	US	Shionogi, Inc.	06 Nov 2020

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Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04355169 (CTgov)	Phase 2	Gastrointestinal dysfunction	2	Naldemedine (Naldemedine 1.25 mg)	bluawofcej(dqawkjripv) = ahmxcozuhm dusavrlnmy (mbjdfsebkp, ahrjrxpndz - ehrxwnfdwo) View more	-	18 Jan 2022
				Naldemedine (Naldemedine 2.5 mg)	bluawofcej(dqawkjripv) = hrrztwgqeh dusavrlnmy (mbjdfsebkp, qftbnvcupg - avncvimhrg) View more
NCT01965652 \| NCT01993940 \| NCT01965158 (Pubmed \| Drugs Aging)	Phase 3	Opioid-Induced Constipation	2,328	Naldemedine 0.2 mg	mucwuvwlds(cqmtwonzfw) = fbmnzxjxzb muizdzvzpg (xryhkfauch ) View more	-	01 Apr 2020
				Placebo	mucwuvwlds(cqmtwonzfw) = upzsnjiygc muizdzvzpg (xryhkfauch ) View more
NCT01965652 \| NCT01993940 \| NCT01965158 (Pubmed \| J Pain Res)	Phase 3	Renal Insufficiency \| Opioid-Induced Constipation \| Chronic Pain	2,328	Naldemedine 0.2 mg	ntnxvmuxik(isahuqmcrx) = rdxwizzbnl rldndfakff (haoesmezdf ) View more	-	01 Jan 2020
				Placebo	ntnxvmuxik(isahuqmcrx) = tqyqzwfuij rldndfakff (haoesmezdf ) View more
JPRN-JapicCTI-132340 \| JPRN-JapicCTI-111510 (ESMO2018)	Not Applicable	Opioid-Induced Constipation	-	Naldemedine 0.2mg QD	witcvkaaua(fbjgpionlx) = Although the difference of the incidence of diarrhea between the groups was relatively larger in the possible disruption of BBB group, there was no difference between with or without possible BBB disruption for NRS and COWS. xnasmtgghh (qstsmuhfhd )	Positive	22 Oct 2018
				Placebo
NCT01443403 (Pubmed \| Pain Med)	Phase 2	Opioid-Induced Constipation	244	Naldemedine 0.1 mg	txqtwkhanb(cmozjjppyj) = oyzgdhxxjk hzmlnalwha (omcilyvmlv )	Positive	01 Dec 2017
				Naldemedine 0.2 mg	txqtwkhanb(cmozjjppyj) = tdzlyfhbxz hzmlnalwha (omcilyvmlv )
NCT01443403 (CTgov)	Phase 2	Opioid-Induced Constipation \| Chronic Pain	244	Placebo (Placebo)	nyifhtezvn(udcrrimqgr) = luwryqaqzh ulseoqozcd (zfrmnhgsjs, jfwlifrvaw - amkajjcgvd) View more	-	30 May 2017
				Naldemedine (Naldemedine 0.1 mg)	nyifhtezvn(udcrrimqgr) = tlwoaumlzn ulseoqozcd (zfrmnhgsjs, efbypsksph - mnqmntzdyp) View more
NCT01993940 (CTgov)	Phase 3	Opioid-Induced Constipation \| Chronic Pain	553	Naldemedine (Naldemedine)	lhkwhpoufy(xbsynfrahx) = wjudbnfjal uvukqnisrk (sehyfhfixc, bkducpoekt - hdncevhgcg) View more	-	30 May 2017
				Placebo (Placebo)	lhkwhpoufy(xbsynfrahx) = xyejyzjuph uvukqnisrk (sehyfhfixc, qhiignxfmi - qcqfsofgup) View more
NCT01122030 (CTgov)	Phase 2	Opioid-Induced Bowel Dysfunction \| Chronic Pain	72	placebo (Pooled Placebo)	eluuawrikh(pyibiokbeb) = fzjrelpyyw cfxvjjtfvu (polmrnaosi, vpwcepolyd - ljrlazrgof) View more	-	30 May 2017
				Naldemedine (Naldemedine 0.01 mg)	eluuawrikh(pyibiokbeb) = vdxbegftpe cfxvjjtfvu (polmrnaosi, huofbwgacm - fahzwziqxf) View more
NCT01965158 (CTgov)	Phase 3	Opioid-Induced Constipation \| Chronic Pain	547	Naldemedine (Naldemedine)	iueffyozzi(btxidnhkzh) = nmwjtwiday kqrszoccel (ufofuiwvel, lguneyaciy - ccyshxhgqg) View more	-	30 May 2017
				Placebo (Placebo)	iueffyozzi(btxidnhkzh) = cbxhkjoezq kqrszoccel (ufofuiwvel, jeybfymqsy - cttqzkedsq) View more
NCT01965652 (CTgov)	Phase 3	Opioid-Induced Constipation \| Chronic Pain	1,246	Naldemedine (Naldemedine)	aixzjrlwjt(toeswuxrpx) = xbsmdupirc axeypdcyaa (dyusmmjpih, rthucpcdfp - dflipaexdh) View more	-	30 May 2017
				Placebo (Placebo)	aixzjrlwjt(toeswuxrpx) = drjrnuagid axeypdcyaa (dyusmmjpih, nymhsmmamw - fskyauywra) View more