Delving into the Latest Updates on Naloxone Hydrochloride/Oxycodone Hydrochloride with Synapse

Main purpose: To evaluate the bioequivalence of the oxycodone-naloxone sustained-release tablets produced by Gansu Nongken Drug Alkali Factory Co., Ltd. with the reference preparation (trade name: Targinact, Napp Pharmaceuticals Limited) marketed overseas; Secondary purpose: To evaluate the safety of the oxycodone-naloxone sustained-release tablets produced by Gansu Nongken Drug Alkali Factory Co., Ltd.

Start Date20 Jun 2024

Sponsor / Collaborator

Gansu Nongken Pharmaceutical Alkali Factory Co., Ltd.

NCT06212830

/ Not yet recruitingEarly Phase 1IIT

Enhancing Pain Relief After Corneal Collagen Cross-Linking: Exploring New Post-Surgical Treatments

Keratoconus is a progressive corneal ectasia that can lead to significant visual impairment and decreased quality of life. The introduction of corneal cross-linking (CXL) with riboflavin and ultraviolet-A (UVA) light has revolutionized the treatment of keratoconus by increasing corneal rigidity and arresting disease progression. The epithelium-off protocol, which induces heightened post-surgical discomfort, is the prevailing approach. Despite the success of CXL, postoperative pain is a common side effect that can negatively impact patients' quality of life and impede recovery.
Pain management after CXL is essential for optimizing patient outcomes and satisfaction. Systemic painkillers, though not researched enough, may potentially aid in healing and recovery, minimizing complications and discomfort for the patient.
In this study we will provide evidence-based recommendations for clinicians to optimize pain control after CXL in collaboration with pain specialists.

Start Date01 Feb 2024

Sponsor / Collaborator

Assaf Harofeh Medical Center

CTR20233379

/ TerminatedNot Applicable

羟考酮纳洛酮缓释片的人体生物等效性研究（预试验）

[Translation] Bioequivalence study of oxycodone-naloxone sustained-release tablets in humans (preliminary study)

主要目的：以江苏恩华药业股份有限公司研制、生产的羟考酮纳洛酮缓释片（规格：40 mg/20 mg）为受试制剂，以Napp Pharmaceuticals Limited生产的羟考酮纳洛酮缓释片（TARGINACT，规格：40 mg/20 mg）为参比制剂，研究受试制剂和参比制剂在中国慢性疼痛受试者中空腹/餐后条件下单剂量给药时的药代动力学特征，并初步评价两制剂空腹/餐后条件下的人体生物等效性，为后期正式生物等效性试验方案的采血点设计等提供依据。次要目的：观察中国慢性疼痛受试者单次空腹/餐后口服受试制剂和参比制剂的安全性。

[Translation]

Main purpose: Using the oxycodone-naloxone sustained-release tablets (specification: 40 mg/20 mg) developed and produced by Jiangsu Enhua Pharmaceutical Co., Ltd. as the test preparation and the oxycodone-naloxone sustained-release tablets (TARGINACT, specification: 40 mg/20 mg) produced by Napp Pharmaceuticals Limited as the reference preparation, the pharmacokinetic characteristics of the test preparation and the reference preparation when administered in a single dose under fasting/postprandial conditions in Chinese chronic pain subjects were studied, and the human bioequivalence of the two preparations under fasting/postprandial conditions was preliminarily evaluated, providing a basis for the design of blood sampling points in the later formal bioequivalence test plan. Secondary purpose: To observe the safety of the test preparation and the reference preparation when administered orally in a single fasting/postprandial dose in Chinese chronic pain subjects.

Start Date08 Dec 2023

Sponsor / Collaborator

Jiangsu Nhwa Pharmaceutical Co., Ltd.

100 Clinical Results associated with Naloxone Hydrochloride/Oxycodone Hydrochloride

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100 Translational Medicine associated with Naloxone Hydrochloride/Oxycodone Hydrochloride

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100 Patents (Medical) associated with Naloxone Hydrochloride/Oxycodone Hydrochloride

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42

Literatures (Medical) associated with Naloxone Hydrochloride/Oxycodone Hydrochloride

01 Mar 2023·Annals of Clinical and Translational Neurology

No pain, no strain: Targin® mitigates pain and constipation following spinal cord injury

Author: Berger, Michael ; Hosseinzadeh, Ali ; Rizzardo, Aaron ; Maharaj, Andrea ; Sachdeva, Rahul ; Krassioukov, Andrei

AbstractBackgroundOpioids effectively reduce chronic pain, but present significant side effects including opioid‐induced constipation. Oxycodone/naloxone decreases pain and constipation in cancer patients, however its effect on spinal cord injury population remains understudied.MethodsWe assessed whether oxycodone/naloxone reduces pain, constipation, and severity of autonomic dysreflexia in an individual with spinal cord injury. A 55‐year‐old male with C5 lesion presented with chief complaint of chronic pain received 5/2.5 mg and 20/10 mg oxycodone/naloxone for 6 and 2 weeks, respectively.ResultsOxycodone/naloxone improved pain, bowel function, and autonomic dysreflexia severity.InterpretationOxycodone/naloxone was effective in managing chronic pain and constipation in the studied case.

01 Nov 2020·Journal of Orthopaedics

Perioperative steroid administration improves knee function and reduces opioid consumption in bilateral total knee arthroplasty

Article

Author: Keohane, David ; Sheridan, Gerard ; Harty, James

INTRODUCTIONThe benefits of steroid usage have been well described for unilateral total knee arthroplasty (TKA), however it's benefits in bilateral TKA has not been well published in the literature. We describe the impact of perioperative steroid administration in a cohort of bilateral TKAs (74 knees) with regard to immediate postoperative knee function, postoperative knee strength and opioid consumption.MATERIALS AND METHODSWe report on a single-surgeon consecutive case series of simultaneously-performed bilateral TKAs. Eighteen patients received 2 doses of 8 mg IV dexamethasone in the perioperative setting. There were 19 patients in the control group. Primary outcome measures were day 1 postoperative knee flexion (degrees), knee strength and postoperative analgesic requirements (mg/mcg). Morphine dose equivalents (MDE) were calculated to compare all opioid-based analgesics. Secondary outcomes included post-operative pain according to the VAS (at 24, 48 and 72 h), anti-emetic requirements (mg) and length of stay (days).RESULTSThe mean knee flexion achieved day 1 in the steroid group was 70.1°(σ = 17.64, 95% CI 64.1-76.0) compared to 55.8° in the non-steroid group (σ = 19.8, 95% CI 49.2-62.3) (p = 0.0008). Regarding the straight leg raise, 88.9% of the steroid group were able to achieve this compared to only 55.2% of the non-steroid group (p = 0.002). There was a reduction in the MDE requirement per patient across all medications for the 'steroid' group. Both Targin® (p = 0.03) (Prolonged-Release Oxycodone) and Fentanyl (p = 0.01) requirements were significantly reduced in the 'steroid' group.CONCLUSIONWe recommend the use of perioperative steroids in bilateral TKA to allow accelerated rehabilitation, improved immediate knee function and an overall reduction in the consumption of potentially problematic opioid-based analgesics.

01 Mar 2020·Advances in TherapyQ3 · MEDICINE

Prolonged-Release (PR) Oxycodone/Naloxone Improves Bowel Function Compared with Oxycodone PR and Provides Effective Analgesia in Chinese Patients with Non-malignant Pain: A Randomized, Double-Blind Trial

Q3 · MEDICINE

Article

Author: Chen, Gouzhong ; Lu, Guodong ; Huang, Ming ; Weng, Xisheng ; Yao, Shanglong ; Leng, Xiaomei ; Zeng, Xiaofeng ; Zhang, Fengxiao ; Huang, Yuguang ; Lu, Kaizhi ; Hopp, Michael

INTRODUCTIONProlonged-release oxycodone/naloxone (OXN PR), combining an opioid analgesic with selective blockade of enteric µ-opioid receptors, provided effective analgesia and improved bowel function in patients with moderate-to-severe pain and opioid-induced constipation in clinical trials predominantly conducted in Western countries. This double-blind randomized controlled trial investigated OXN PR (N = 116) versus prolonged-release oxycodone (OXY PR, N = 115) for 8 weeks at doses up to 50 mg/day in patients with moderate-to-severe, chronic, non-malignant musculoskeletal pain and opioid-induced constipation recruited in China.METHODSA total of 234 patients at least 18 years of age with non-malignant musculoskeletal pain for more than 4 weeks that was moderate-to-severe in intensity and required round-the-clock opioid therapy were randomized (1:1) to OXN PR or OXY PR. The primary endpoint was bowel function using the Bowel Function Index (BFI). Secondary endpoints included safety, Brief Pain Inventory-Short Form (BPI-SF), use of analgesic and laxative rescue medication, and health-related quality of life (EQ-5D).RESULTSWhile BFI scores were comparable at baseline, at week 8 improvements were greater with OXN PR vs OXY PR (least squares mean [LSM] difference (95% CI) - 9.1 (- 14.0, - 4.2); P < 0.001. From weeks 2 to 8, mean BFI scores were in the range of normal bowel function (≤ 28.8) with OXN PR but were in the range of constipation (> 28.8) at all timepoints with OXY PR. Analgesia with OXN PR was similar and non-inferior to OXY PR on the basis of modified BPI-SF average 24-h pain scores at week 8: LSM difference (95% CI) - 0.3 (- 0.5, - 0.1); P < 0.001. The most frequent treatment-related AEs were nausea (OXN PR 5% vs OXY PR 6%) and dizziness (4% vs 4%).CONCLUSIONOXN PR provided clinically meaningful improvements in bowel function and effective analgesia in Chinese patients with moderate-to-severe musculoskeletal pain and pre-existing opioid-induced constipation.TRIAL REGISTRATIONClinicalTrials.gov, identifier NCT01918098.

100 Deals associated with Naloxone Hydrochloride/Oxycodone Hydrochloride

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pain	China	Napp Pharmaceuticals Ltd.	22 Nov 2022
Opioid-Induced Constipation	Australia	Mundipharma Pty Ltd.	12 May 2010
Restless Legs Syndrome	Australia	Mundipharma Pty Ltd.	12 May 2010
Severe pain	Australia	Mundipharma Pty Ltd.	12 May 2010

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cancer Pain	NDA/BLA	China	Luye Pharma AG	30 Jan 2022
Pain	Discovery	United States	Purdue Pharma LP	23 Jul 2014
Chronic osteoarthritis	Discovery	Germany	Mundipharma Research GmbH & Co. KG	01 May 2009
Chronic osteoarthritis	Discovery	Czechia	Mundipharma Research GmbH & Co. KG	01 May 2009
Chronic osteoarthritis	Discovery	Hungary	Mundipharma Research GmbH & Co. KG	01 May 2009
Chronic osteoarthritis	Discovery	Finland	Mundipharma Research GmbH & Co. KG	01 May 2009
Constipation	Discovery	-	Mundipharma Research GmbH & Co. KG	01 Jan 2006
Opioid-Induced Constipation	Discovery	-	Mundipharma Research GmbH & Co. KG	01 Jan 2006
Chronic Pain	Discovery	-	Mundipharma Research GmbH & Co. KG	01 Jan 2005

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02880475 (CTgov)	Phase 1	Chronic Pain	30	OXN PR tablet (OXN Prolonged Release Tablet 5/2.5mg)	vdquhgnjgw(uozyfxddcb) = cexndmimhk vzhkclhkcb (zqsnbkjkih, lauxjhhoya - fpohrxqvta) View more	-	17 Jul 2019
				OXN PR tablet (OXN Prolonged Release Tablet 20/10mg)	vdquhgnjgw(uozyfxddcb) = opfiniduho vzhkclhkcb (zqsnbkjkih, avlyccathc - ymmjquyawn) View more
NCT02680847 (CTgov)	Phase 4	Analgesia	32	ALO-02 (ALO-02 <= 20 mg)	ommqhumbat(dsrplpcdxt) = gfyiivreod lbhhxlpxkq (tjdwtujfsr, gfuwdmufvo - wghcyqlbta) View more	-	25 Sep 2018
				ALO-02 (ALO-02 >20-40 mg)	ommqhumbat(dsrplpcdxt) = qubneotuuv lbhhxlpxkq (tjdwtujfsr, qrslahdtmk - mlnrjgtohs) View more
NCT02293785 (GREAT, ASCO2017)	Not Applicable	Pain	206	Oxycodone-naloxone	sgmnyxlxph(qtfxmuokji) = ibnmjlmrut yyjxgbrjup (uipwlnqrkq ) View more	-	30 May 2017
NCT01571362 (CTgov)	Phase 3	Low Back Pain \| Analgesia \| Chronic Pain	410	Placebo+ALO-02 (ALO-02 To Placebo)	gsotpktjga(axbgkuacej) = wfriucwwgz rkprgowgig (ityemkezvd, sddelalsfx - yihiccxrwr) View more	-	04 Apr 2017
				AL0-02+ALO-02+oxycodone (ALO-02 To ALO-02)	gsotpktjga(axbgkuacej) = zxrkflcyxn rkprgowgig (ityemkezvd, idwpmvndyr - rqqbzhwwiv) View more
NCT02109640 (TACS, CTgov)	Phase 3	Postoperative Nausea and Vomiting \| Pain, Postoperative	50	Laparoscopic segmental colectomy+Targinact (Targinact)	aqokznfxot(zqoovaapdo) = ainhurabjk rprdxpcsff (zivyvckqks, zrdhfqjtdg - ljterukjld) View more	-	29 Mar 2017
				Laparoscopic segmental colectomy+Oxycodone (Oxycodone)	aqokznfxot(zqoovaapdo) = iralqbysgp rprdxpcsff (zivyvckqks, yyljzkayfh - vzldvrqhtg) View more
NCT01112644 (Pubmed \| CNS Drugs)	Phase 3	Restless Legs Syndrome	205	Prolonged release oxycodone/naloxone (OXN PR)	gppvomojtn(btmvguycrk) = dsrdpljfbp bcqrluoibb (gbavgguwwg, 0.43 - 1.11)	-	01 Aug 2016