Tolerability of Biphasic-Release Hydrocodone Bitartrate/Acetaminophen Tablets (MNK-155): A Phase III, Multicenter, Open-Label Study in Patients With Osteoarthritis or Chronic Low Back Pain

Zheng, Yunfei; Kostenbader, Kenneth; Barrett, Thomas; Hisaw, E.; Giuliani, Michael J.; Yin, Changchun; Young, Jack

doi:10.1016/j.clinthera.2015.03.019

Cited by 6 publications

(5 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Despite the higher AUC in subjects with hepatic impairment, the elimination half-life was comparable between subjects with normal hepatic function and those with hepatic impairment. The higher systemic exposure in subjects with hepatic or renal impairment was not associated with an increased incidence of AEs, and AEs were consistent with the known safety profiles of hydrocodone [27][28][29] and naltrexone. 3 This substantially decreases the first-pass metabolism of orally administered drugs, leading to a greater proportion of drug entering systemic circulation and resulting in a significant increase in the extent of absorption.…”

Section: Discussionsupporting

confidence: 78%

“…3 Hydrocodone ER was generally well tolerated after single 45-mg doses administered with naltrexone blockade in study 1 and single 15-mg doses administered without naltrexone blockade in study 2. The higher systemic exposure in subjects with hepatic or renal impairment was not associated with an increased incidence of AEs, and AEs were consistent with the known safety profiles of hydrocodone [27][28][29] and naltrexone. 30…”

Section: Discussionsupporting

confidence: 78%

See 1 more Smart Citation

Effects of Renal Impairment and Hepatic Impairment on the Pharmacokinetics of Hydrocodone After Administration of a Hydrocodone Extended‐Release Tablet Formulated With Abuse‐Deterrence Technology

Darwish

Yang

Tracewell

et al. 2016

Clinical Pharm in Drug Dev

View full text Add to dashboard Cite

Two open-label, single-dose, parallel-group studies assessed effects of renal and hepatic impairment on the pharmacokinetics of a hydrocodone extended-release (ER) formulation developed with the CIMA Abuse-Deterrence Technology platform. Forty-eight subjects with normal renal function or varying degrees of renal impairment received hydrocodone ER 45 mg (study 1); 16 subjects with normal hepatic function or moderate hepatic impairment received hydrocodone ER 15 mg (study 2). Blood samples were obtained predose and through 144 hours postdose. Mean maximum observed plasma hydrocodone concentration (Cmax ) in subjects with normal renal function, mild, moderate, and severe impairment, and end-stage renal disease was 28.6, 33.4, 42.4, 36.5, and 31.6 ng/mL, and mean area under the plasma hydrocodone concentration-versus-time curve from time 0 to infinity (AUC0-∞ ) was 565, 660, 973, 983, and 638 ng·h/mL, respectively. Incidence of adverse events was 57%, 38%, 44%, 33%, and 56%, respectively. Mean Cmax with normal hepatic function and moderate impairment was 10.1 and 13.0 ng/mL, and mean AUC0-∞ was 155 and 269 ng·h/mL, respectively. Incidence of adverse events was 38% in both groups. Altered systemic exposure in renally or hepatically impaired populations (up to ∼70% higher) should be considered when titrating to an effective dose of hydrocodone ER.

show abstract

Section: Discussionsupporting

confidence: 78%

Section: Discussionsupporting

confidence: 78%

Effects of Renal Impairment and Hepatic Impairment on the Pharmacokinetics of Hydrocodone After Administration of a Hydrocodone Extended‐Release Tablet Formulated With Abuse‐Deterrence Technology

Darwish

Yang

Tracewell

et al. 2016

Clinical Pharm in Drug Dev

View full text Add to dashboard Cite

show abstract

“…As the release of tazarotene drugs from the nanofibers could be regulated by the nanopores on the nanofibers, the sustained-release system which could deliver tazarotene with appropriate concentrations and continue for a long-term period was established. According to the results in Figure , both the aligned and random drug-loaded PCL fibrous membrane samples followed the classical biphasic release law . The result also showed a sufficient release during the initial 1 day and then a slow release over a period of more than 14 days.…”

Section: Discussionmentioning

confidence: 72%

“…According to the results in Figure 4, both the aligned and random drugloaded PCL fibrous membrane samples followed the classical biphasic release law. 64 The result also showed a sufficient release during the initial 1 day and then a slow release over a period of more than 14 days. The period during which the drug was released was substantially consistent with the time phase of initial basic revascularization.…”

Section: Discussionmentioning

confidence: 77%

Tazarotene Released from Aligned Electrospun Membrane Facilitates Cutaneous Wound Healing by Promoting Angiogenesis

Zhu

Liu

Xue

et al. 2019

ACS Appl. Mater. Interfaces

View full text Add to dashboard Cite

Wound treatment is a long-lasting clinical issue. Poor angiogenesis leading to delayed wound closure causes huge challenges for healing. Functional electrospun membranes have been established as an efficient strategy to promote wound recovery by protecting and improving vascular regeneration. Here, we aimed to investigate the effect of tazarotene, an active drug for angiogenesis, loaded in aligned electrospun nanofibrous barrier on a soft tissue wound. This aligned membrane was arranged in a single direction, and tazarotene could be released from its nanofibers sustainably. The in vitro study demonstrated that compared with the random drug-loaded or other control groups, the aligned tazarotene-loaded membranes [poly-caprolactone (PCL)/AT] could stimulate proliferation, migration, angiogenesis, and vascular endothelial growth factor secretion and its gene expression of human umbilical vein endothelial cells. Furthermore, the in vivo model showed that the prepared tazarotene-loaded aligned membrane significantly accelerated the speed of healing, improved the neovascularization and re-epithelialization, and inhibited the inflammatory reaction in the wound area. All these results above indicated that the PCL/AT nanofibrous dressing, which could promote angiogenesis because of both stimulation of structure and chemical signals, is a promising wound-caring material.

show abstract

“…Thirteen patients had abnormal liver function test results but did not have acute liver failure. Thus, the safety profile of this product was similar to other opioid products, but its use in chronic pain patients must be subject to further study [15].…”

Section: Hydrocodone and Acetaminophenmentioning

confidence: 96%

Fixed Dose Versus Loose Dose: Analgesic Combinations

Pergolizzi¹,

Varrassi²,

LeQuang³

et al. 2023

Cureus

View full text Add to dashboard Cite

Combinations of drugs may be fixed (two or more entities in a single product) or loose (two or more agents taken together but as individual agents) to help address multimechanistic pain. The use of opioids plus nonopioids can result in lower opioid consumption without sacrificing analgesic benefits. Drug combinations may offer additive or synergistic benefits. A variety of fixed-dose combination products are available on the market such as diclofenac plus thiocolchicoside, acetaminophen and caffeine, acetaminophen and opioid, ibuprofen and acetaminophen, tramadol and acetaminophen, and others. Fixeddose combination products offer predictable pharmacokinetics and pharmacodynamics, known adverse events, and can reduce the pill burden. However, they are limited to certain drug combinations and doses; loose dosing allows prescribers the versatility to meet individual patient requirements as well as the ability to titrate as needed. Not all drug combinations offer synergistic benefits, which depend on the drugs and their doses. Certain drugs offer dual mechanisms of action in a single molecule, such as tapentadol, and these may further be used in combination with other analgesics. New technology allows for co-crystal productions of analgesic agents which may further improve drug characteristics, such as bioavailability. Combination analgesics are important additions to the analgesic armamentarium and may offer important benefits at lower doses than monotherapy.

show abstract

Tolerability of Biphasic-Release Hydrocodone Bitartrate/Acetaminophen Tablets (MNK-155): A Phase III, Multicenter, Open-Label Study in Patients With Osteoarthritis or Chronic Low Back Pain

Cited by 6 publications

References 20 publications

Effects of Renal Impairment and Hepatic Impairment on the Pharmacokinetics of Hydrocodone After Administration of a Hydrocodone Extended‐Release Tablet Formulated With Abuse‐Deterrence Technology

Effects of Renal Impairment and Hepatic Impairment on the Pharmacokinetics of Hydrocodone After Administration of a Hydrocodone Extended‐Release Tablet Formulated With Abuse‐Deterrence Technology

Tazarotene Released from Aligned Electrospun Membrane Facilitates Cutaneous Wound Healing by Promoting Angiogenesis

Fixed Dose Versus Loose Dose: Analgesic Combinations

Contact Info

Product

Resources

About