A Randomized, Double-blind, Placebo- and Active-controlled Trial to Investigate the Single-dose Efficacy, Safety, and Pharmacokinetics of 250 and 1000 mg JNJ-10450232 in Postoperative Dental Pain

To assess the safety and effectiveness one dose of a new pain reliever medicine (JNJ-10450232 at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or acetaminophen 1000 mg after surgical removal of third molars. The primary endpoint will evaluate pain relief effectiveness up to 6 hours after administration of the study drug.

开始日期2014-08-01

申办/合作机构

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

100 项与 JNJ-10450232 相关的临床结果

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100 项与 JNJ-10450232 相关的转化医学

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100 项与 JNJ-10450232 相关的专利（医药）

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项与 JNJ-10450232 相关的文献（医药）

2023-08-01·Regulatory Toxicology and Pharmacology

JNJ-10450232 (NTM-006), A novel non-opioid with structural similarities to acetaminophen, produces relatively long-lasting analgesia after a single dose in patients undergoing 3rd molar extraction

Article

作者: Mishra, Rajesh ; Gelotte, Cathy K ; Vakil, Amy M ; Kuffner, Edwin K ; Zimmerman, Brenda A ; Flores, Christopher M ; Zannikos, Peter ; Eichenbaum, Gary

JNJ-10450232 (NTM-006) is a non-opioid, non-NSAID analgesic and antipyretic compound with structural similarity to acetaminophen. Preclinical models show comparable analgesia relative to acetaminophen and no evidence of hepatotoxicity associated with overdose. Moreover, it was safe and generally well tolerated in a First-in-Human Study. This single-dose, single-center, inpatient, randomized, double-blind study in moderate-to-severe acute pain following third molar extraction compared efficacy and safety of 250 mg and 1000 mg JNJ-10450232 (NTM-006), 1000 mg acetaminophen, and placebo during the 24 h following administration. While onset of action of 1000 mg JNJ-10450232 (NTM-006) was relatively slower compared with acetaminophen, its duration of action was sustained up to 24 h being superior beginning 7 h after administration. No clinically important differences among treatment groups in nature or severity of adverse events were observed and no serious adverse events were reported. Increased bilirubin, potentially due to UGT1A1 inhibition and ingestion of blood from oral surgery, was the most commonly reported adverse event and the only event reported by ≥ 5% of subjects across treatment groups. These data support further evaluation of JNJ-10450232 (NTM-006) for the treatment of moderate-to-severe pain. CLINICALTRIALS.GOV ID: NCT02209181.

2023-03-01·Regulatory Toxicology and Pharmacology

Metabolism and disposition of JNJ-10450232 (NTM-006) in rats, dogs, monkeys and humans

Article

作者: Salter, Rhys ; Kuffner, Edwin K. ; Gelotte, Cathy K. ; Gong, Yong ; Lam, Wing ; Chen, Jie ; Silva, Jose ; Lim, Heng-Keang ; Vakil, Amy M. ; Eichenbaum, Gary E. ; Flores, Christopher M. ; Berwaerts, Joris ; Leclercq, Laurent

JNJ-10450232 (NTM-006), a novel non-opioid, non-nonsteroidal anti-inflammatory drug with structural similarities to acetaminophen, demonstrated anti-pyretic and/or analgesic activities in preclinical models and humans and reduced potential to cause hepatotoxicity in preclinical species. Metabolism and disposition of JNJ-10450232 (NTM-006) following oral administration to rats, dogs, monkeys and humans are reported. Urinary excretion was the major route of elimination based on recovery of 88.6% (rats) and 73.7% (dogs) of oral dose. The compound was extensively metabolized based on low recovery of unchanged drug in excreta from rats (11.3%) and dogs (18.4%). Clearance is driven by O-glucuronidation, amide hydrolysis, O-sulfation and methyl oxidation pathways. The combination of metabolic pathways driving clearance in human is covered in at least one preclinical species despite a few species-dependent pathways. O-Glucuronidation was the major primary metabolic pathway of JNJ-10450232 (NTM-006) in dogs, monkeys and humans, although amide hydrolysis was another major primary metabolic pathway in rats and dogs. A minor bioactivation pathway to quinone-imine is observed only in monkeys and humans. Unchanged drug was the major circulatory component in all species investigated. Except for metabolic pathways unique to the 5-methyl-1H-pyrazole-3-carboxamide moiety, metabolism and disposition of JNJ-10450232 (NTM-006) are similar to acetaminophen across species.

2023-01-01·Regulatory Toxicology and Pharmacology

Preclinical safety assessment of JNJ-10450232 (NTM-006), a structural analog of acetaminophen, that does not cause hepatotoxicity at supratherapeutic doses

Article

作者: Codd, Ellen E ; Weiner, Sandy ; Gallacher, David ; Zhou, Junguo ; Flores, Christopher M ; Stahle, Paul ; Kelley, Michael F ; Kuffner, Edwin K ; De Jonghe, Sandra ; Eichenbaum, Gary E

JNJ-10450232 (NTM-006) is a new molecular entity that is structurally related to acetaminophen. A comprehensive non-clinical safety program was conducted to support first-in-human and clinical efficacy studies based on preclinical data suggesting that the compound has comparable or enhanced antinociceptive and antipyretic efficacy without causing hepatotoxicity at supratherapeutic doses. No hepatic toxicity was noted in a mouse model sensitive to acetaminophen hepatotoxicity or in rats, dogs, and non-human primates in 28-day repeat dose toxicity studies at and above doses/exposures at which acetaminophen is known to cause hepatotoxicity. In the 28-day toxicity studies, all treatment-related findings were monitorable and reversible. Methemoglobinemia, which was observed in dogs and to a lesser extent in rats, is also observed with acetaminophen. This finding is considered not relevant to humans due to species differences in metabolism. Thyroid hypertrophy and hyperplasia were also observed in dogs and were shown to be a consequence of a species-specific UGT induction also demonstrated with increased thyroid hormone metabolism. Indirect bilirubin elevation was observed in rats as a result of UGT1A1 Inhibition. JNJ-10450232 (NTM-006) had no toxicologically relevant findings in safety pharmacology or genotoxicity studies. Together, these data supported progressing into safety and efficacy studies in humans.

项与 JNJ-10450232 相关的新闻（医药）

2021-01-05

·GlobeNewswire

Neumentum to Participate in Upcoming January Virtual Investor Conferences

MORRISTOWN, N.J., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Neumentum Inc., a pharmaceutical company dedicated to transforming the way pain is treated – without opioids – today announced that Scott Shively, Chief Executive Officer at Neumentum, will present at two upcoming investor conferences in January. About Neumentum: Addressing a National Health Emergency Neumentum is dedicated to becoming a leading non-opioid analgesic and neurology specialty pharmaceutical company with product candidates that have the potential to provide the benefits of safe and effective pain management without the risks of abuse, misuse and diversion seen with opioids, or opioid-induced side effects including potentially life-threatening respiratory depression. Opioid use is considered a critical public health concern in the US. In 2018, 9.9 million people over age of 12 reported misusing prescription opioid pain relievers1, and opioids were involved in 46,802 overdose deaths.2 Opioids also account for over 305,000 emergency department visits annually for non-fatal overdoses.3 Despite these staggering statistics, and the frequently reported opioid-induced side effects such as nausea, vomiting, constipation and somnolence, 168 million prescriptions – over 51 prescriptions per 100 Americans – were written for opioids in 2018.4 Neumentum has two lead product candidates being developed to directly help address the opioid crisis. NTM-006, a Phase 2 novel oral analgesic with a target indication for moderate to severe chronic pain, was licensed in late 2019. NTM-001 is a Phase 3-ready IV formulation of Toradol (ketorolac), with recent Phase I results showing that it may provide consistent, steady blood plasma levels of ketorolac over 24 hours and durable analgesic effect. This Phase I study is part of a program supporting what has the potential to be the first-ever NSAID approved for continuous infusion. Neumentum is led by a world-wide executive team of biotech and pharmaceutical industry leaders who have extensive experience in pain and neurology, from drug development through commercialization. For more information, visit . INVESTOR CONTACT: Scott ShivelyCEO & Co-founderscottshively@neumentum.com (833) NEUPAIN MEDIA CONTACT:Megan KernanWestwicke, an ICR companymegan.kernan@westwicke.com(952) 221-2096 ______________________ [1] SAMSHA, Key Substance Use and Mental Health Indicators in the US: Results from the 2018 National Survey on Drug Use and Health. P13, Fig 10.[2] Wilson N, Kariisa M, Seth P, Smith H IV, Davis NL. MMWR Morb Mortal Wkly Rep 2020; 69:290–297[3] Vivolo-Kantor AM, Hoots BE, Scholl L, et al. MMWR Morb Mortal Wkly Rep 2020;69:371–376[4] , accessed 16 Jul 2020

合作

2020-09-03

·BioSpace

Neumentum Announces Two Poster Presentations for Novel Non-opioid, Non-NSAID Analgesic Drug Candidate at PAINWeek 2020

MORRISTOWN, N.J., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Neumentum Inc., a pharmaceutical company dedicated to transforming the way pain is treated – without opioids – will present two posters with data on NTM-006, a new chemical entity (NCE) non-opioid, non-NSAID analgesic candidate that may have the potential to replace opioids, at PAINWeek 2020 Live Virtual Conference, being held on September 11-13, 2020. The following poster presentations will be available on the PAINWeek 2020 website: Summary of the Preclinical Pharmacology of NTM-006 (formerly JNJ-10450232): A Novel Orally-Active Non-Opioid Analgesic Presenter: Robert B. Raffa, PhD, Chief Scientific Officer of Neumentum Poster ID: 20 Efficacy and Safety of NTM-006 in a Randomized, Double-Blind, Placebo- and Active-Controlled Trial in Moderate to Severe Pain after Third Molar Extraction Presenter: Ilona Steigerwald, MD, Chief Medical Officer of Neumentum Poster ID: 22 For further information, please visit “We are making significant advances with our portfolio of assets that provide benefits of safe and effective pain management,” said Scott Shively, Chief Executive Officer of Neumentum. “With continued research, we are striving to develop novel non-opioid products to treat pain, both in the U.S. and around the world.” “Chronic pain significantly impacts the lives of many Americans,” said Dr. Joseph Pergolizzi, Executive Chairman of Neumentum. “Our mission at Neumentum is to develop options that reduce pain, improve outcomes, and address the unmet needs of chronic and acute pain,” he added. Neumentum’s NTM-006 is a non-opioid, non-NSAID, non-gabapentinoid NCE, with a novel mechanism of action, which has demonstrated analgesic activity in a phase IIa study. It is in development targeting a once-daily, orally administered treatment for chronic neuropathic and nociplastic pain. Neumentum is also developing NTM-001, a novel, alcohol-free formulation of ketorolac in a convenient to use pre-mixed bag for continuous 24 hours IV infusion, for the treatment of moderately severe acute pain requiring analgesia at the opioid level, usually in a postoperative setting with the benefit of consistent pain relief without the risks associated with opioids, or the disadvantages of bolus ketorolac. Neumentum recently shared a corporate update on the progression of its pipeline of non-opioid analgesic programs. About Neumentum: Addressing a National Health Emergency Opioid use is considered a critical public health concern in the US. In 2018, 9.9 million people over age of 12 reported misusing prescription opioid pain relievers1, and opioids were involved in 46,802 overdose deaths2. Opioids also account for over 305,000 emergency department visits annually for non-fatal overdoses3. Despite these staggering statistics, and the frequently reported opioid-induced side effects such as nausea, vomiting, constipation and somnolence, 168 million prescriptions– over 51 prescriptions per 100 Americans–were written for opioids in 20184. Neumentum is dedicated to becoming a leading non-opioid analgesic and neurology specialty pharmaceutical company with product candidates that have the potential to provide the benefits of safe and effective pain management, without the risks for abuse, misuse and diversion seen with opioids or the opioid-induced side effects including potentially life-threatening respiratory depression. Neumentum is led by a world-wide executive team of biotech and pharmaceutical industry leaders who have extensive experience in pain and neurology, from drug development through commercialization. For more information, visit . INVESTOR CONTACT: Scott Shively CEO & Co-founder scottshively@neumentum.com (833) NEUPAIN MEDIA CONTACT: Surabhi Verma Westwicke, an ICR company Surabhi.Verma@westwicke.com 646-677-1825 [1] SAMSHA, Key Substance Use and Mental Health Indicators in the US: Results from the 2018 National Survey on Drug Use and Health. P13, Fig 10. [2] Wilson N, Kariisa M, Seth P, Smith H IV, Davis NL. MMWR Morb Mortal Wkly Rep 2020; 69:290–297 [3] Vivolo-Kantor AM, Hoots BE, Scholl L, et al. MMWR Morb Mortal Wkly Rep 2020;69:371–376 [4] , accessed 16 Jul 2020

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100 项与 JNJ-10450232 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
疼痛	临床2期	美国	Neumentum, Inc.初创企业	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Pubmed 人工标引	临床1期	-	102	JNJ 10450232	(獵糧願遞憲壓範醖積繭) = 選糧襯鹹餘醖繭齋餘鹹選願鏇淵襯獵衊觸積衊 (衊構鬱襯艱齋繭衊醖蓋 )	-	2022-08-04
NCT02209181 (CTgov)	临床2期	牙痛	269	JNJ-10450232 / Not yet marketed (Placebo)	齋鑰鬱築壓簾壓築淵簾(範醖壓憲夢襯願鏇築鹽) = 餘鬱壓鹹選餘膚觸鬱蓋壓網淵鹹製築壓糧壓窪 (願獵憲範獵鏇鹹顧製壓, 壓壓衊願鏇製鹹醖鏇艱 ~ 窪糧壓蓋餘獵獵遞網鏇) 更多	-	2017-02-03
NCT02209181 (CTgov)	临床2期	牙痛	269	Tylenol (Acetaminophen 1000 mg)	齋鑰鬱築壓簾壓築淵簾(範醖壓憲夢襯願鏇築鹽) = 選鑰鑰夢簾廠製鹹築膚壓網淵鹹製築壓糧壓窪 (願獵憲範獵鏇鹹顧製壓, 齋憲齋窪獵衊淵簾繭觸 ~ 積獵膚製鏇蓋膚簾選選) 更多	-	2017-02-03