Nexcyon Pharmaceuticals Inc.

Madison, WI, United States

Nexcyon Pharmaceuticals Inc.

Madison, WI, United States
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Linton D.D.,Nexcyon Pharmaceuticals Inc. | Wilson M.G.,Indiana University | Newbound G.C.,Nexcyon Pharmaceuticals Inc. | Freise K.J.,Nexcyon Pharmaceuticals Inc. | Clark T.P.,Nexcyon Pharmaceuticals Inc.
Journal of Veterinary Pharmacology and Therapeutics | Year: 2012

A prospective, double-blinded, positive-controlled, multicenter, noninferiority clinical study was conducted to evaluate the safety and effectiveness of a long-acting transdermal fentanyl solution (TFS) for the control of postoperative pain. Four hundred forty-five client-owned dogs of various breeds were randomly assigned to receive a single dose of TFS (2.6mg/kg [∼50μL/kg]) (N=223) applied 2-4h prior to surgery or buprenorphine (20μg/kg) (N=222) administered intramuscularly 2-4h prior to surgery and every 6h through 90h. There were 159 (35.7%) males and 286 (64.3%) females ranging from 0.5 to 16years of age and 3 to 98.5kg enrolled. Pain was scored using the modified Glasgow Composite Pain Scale with an a priori dropout criteria of ≥8 (20 maximum score). The one-sided upper 95% confidence interval of the mean difference between fentanyl and buprenorphine treatment failures was 5.6%, which was not greater than the a priori selected margin difference of 15%. Adverse events attributed to either treatment were minimal in impact and were approximately equal between groups. Sustained plasma fentanyl concentrations provided by a single pre-emptive dose of TFS are safe and effective and are noninferior to repeated injections of buprenorphine in controlling postoperative pain over 4days. This long-acting fentanyl formulation provides veterinarians with a novel, registered option for the control of postoperative pain in dogs that improves dosing compliance and potentially mitigates the disadvantages of oral, parenteral, and patch delivered opioids. © 2012 Blackwell Publishing Ltd.


Freise K.J.,Nexcyon Pharmaceuticals Inc. | Newbound G.C.,Nexcyon Pharmaceuticals Inc. | Tudan C.,Della Enterprises, Inc. | Clark T.P.,Nexcyon Pharmaceuticals Inc.
Journal of Veterinary Pharmacology and Therapeutics | Year: 2012

Application of transdermal drugs to different anatomical sites can result in different absorption characteristics. The pharmacokinetics (PKs) and bioequivalence of a single 2.6mg/kg (50μL/kg) dose of a novel, long-acting transdermal fentanyl solution were determined when applied topically to the ventral abdominal or dorsal interscapular skin of 40 healthy laboratory Beagles. The PKs were differentiated by a more rapid initial absorption of fentanyl from the dorsal application site. Mean plasma fentanyl concentrations remained above 0.6ng/mL from 4 to 96h in the dorsal application group and from 8 to 144h in the ventral application group. Bioequivalence analysis demonstrated that the sites were not equivalent; the 90% confidence intervals of the ratio of the geometric means for both the maximum concentration (Cmax) and the area under the curve (AUC) were not contained within the 80-125% interval. The Cmax was 2.34±1.29 (mean±standard deviation) and 2.02±0.84ng/mL for the ventral and dorsal application groups, respectively. The terminal elimination half-lives (t1/2) for both groups were similar with values of 137±58.9 and 117±59.6h for the ventral and dorsal application site groups, respectively. A mean absorption rate of ≥2μg·kg/h was maintained from 2 to 144h following dorsal application and from 2 to 264h following ventral application. These results suggest that transdermal fentanyl solution could be applied as a single dose to the dorsal scapular area 2-4h prior to surgery with analgesia lasting a minimum of 4days. © 2012 Blackwell Publishing Ltd.


Freise K.J.,Nexcyon Pharmaceuticals Inc. | Newbound G.C.,Nexcyon Pharmaceuticals Inc. | Tudan C.,Della Enterprises, Inc. | Clark T.P.,Nexcyon Pharmaceuticals Inc.
Journal of Veterinary Pharmacology and Therapeutics | Year: 2012

Opioid overdose in dogs is manifested by clinical signs such as excessive sedation, bradycardia, and hypothermia. The ability of two different intramuscular (i.m.) naloxone reversal regimens to reverse the opioid-induced effects of a fivefold overdose of long-acting transdermal fentanyl solution was evaluated in dogs. Twenty-four healthy Beagles were administered a single 13mg/kg dose (fivefold overdose) of transdermal fentanyl solution and randomized to two naloxone reversal regimen treatment groups, hourly administration for 8h of 40 (n=8) or 160μg/kg i.m. (n=16). All dogs were sedated and had reduced body temperatures and heart rates (HRs) prior to naloxone administration. Both dosage regimens significantly reduced sedation (P<0.001), and the 160μg/kg naloxone regimen resulted in a nearly threefold lower odds of sedation than that of the 40μg/kg i.m. naloxone regimen (P<0.05). Additionally, naloxone significantly increased the mean body temperatures and HR (P<0.001), although the 160μg/kg regimen increased body temperature and HR more (P<0.05). However, the narcotic side effects of fentanyl returned within 1-3h following termination of the naloxone dosage regimens. The opioid-induced effects of an overdose of transdermal fentanyl solution can be safely and effectively reversed by either 40 or 160μg/kg i.m. naloxone administered at hourly intervals. © 2012 Blackwell Publishing Ltd.


Freise K.J.,Nexcyon Pharmaceuticals Inc. | Linton D.D.,Nexcyon Pharmaceuticals Inc. | Newbound G.C.,Nexcyon Pharmaceuticals Inc. | Tudan C.,Della Enterprises, Inc. | Clark T.P.,Nexcyon Pharmaceuticals Inc.
Journal of Veterinary Pharmacology and Therapeutics | Year: 2012

A novel, long-acting transdermal fentanyl solution (TFS) that delivers sustained plasma fentanyl concentrations following a single application for the control of postoperative pain has recently been approved for use in dogs. The pharmacokinetics (PKs) of this formulation have been evaluated in healthy laboratory dogs, but they have not been reported in a clinical population of dogs for which it is indicated. Plasma fentanyl concentrations were determined from 215 dogs following a single, small-volume (∼50μL/kg) dose of TFS administered 2-4h prior to orthopedic or soft tissue surgery. A population PK model was fit, and a 1-compartment open PK model with first-order absorption and an absorption lag-time best described the data. No tested clinical covariates had a significant effect on the PKs. The final model adequately described the population PKs and gave results consistent with laboratory PK studies in healthy dogs. The PKs were primarily characterized by a rapid initial increase in plasma fentanyl concentrations and a long terminal half-life of 74.0 (95% C.I. [54.7-113])h governed by flip-flop kinetics for the typical subject. The plasma fentanyl concentrations were sustained over days in the range considered to be analgesic for postoperative pain in dogs. © 2012 Blackwell Publishing Ltd.


Kukanich B.,Kansas State University | Clark T.P.,Nexcyon Pharmaceuticals Inc.
Journal of Veterinary Pharmacology and Therapeutics | Year: 2012

Fentanyl is a potent mu opioid receptor agonist that was discovered to identify an improved human health analgesic over morphine, an opioid frequently associated with histamine-release, bradycardia, hyper- or hypotension, and prolonged postoperative respiratory depression. Historically, the pharmacological features of fentanyl have been described primarily through the study of the human approved fentanyl citrate formulation. In conscious dogs, fentanyl has a wide margin of safety, possesses minimum effects on the cardiovascular and respiratory systems, and is readily reversible. Other pharmacological features include sedation, mild reductions in body temperature, and dose-dependent reduction in food intake. The short duration of effect of available fentanyl citrate solutions has limited its clinical use to perioperative injections or constant rate infusions (CRIs). To extend the analgesic effect, additional fentanyl delivery technologies have been developed for human health including the fentanyl patch that has been used in an extra-label manner in dogs. Beyond the slow onset and variability in fentanyl delivery, several additional disadvantages have precluded common use of patches in dogs. The recent approval of long-acting transdermal fentanyl solution for dogs provides a new approach for sustained delivery of fentanyl for the control of postoperative pain in dogs. It has a rapid onset of action, prolonged duration, and mitigates the disadvantages of oral, parenteral, and patch-delivered opioids. The availability of a safe and effective approved opioid in dogs may allow further optimization of postoperative analgesia in this species. The objective of this review is to summarize the history and pharmacology of fentanyl and to integrate information about the newly approved long-acting transdermal fentanyl solution. © 2012 Blackwell Publishing Ltd.


Trademark
Nexcyon Pharmaceuticals Inc. | Date: 2010-09-27

Veterinary pharmaceutical preparations for the therapeutic treatment of disease and parasites in animals.


Trademark
Nexcyon Pharmaceuticals Inc. | Date: 2014-02-06

Pharmaceutical and veterinary preparations for the diagnosis or treatment of internal diseases in dogs and cats.


Trademark
Nexcyon Pharmaceuticals Inc. | Date: 2014-02-06

Pharmaceutical and veterinary preparations for the diagnosis or treatment of internal diseases in dogs and cats.


Trademark
Nexcyon Pharmaceuticals Inc. | Date: 2014-02-06

Pharmaceutical and veterinary preparations for the diagnosis or treatment of internal diseases in dogs and cats.


Trademark
Nexcyon Pharmaceuticals Inc. and Procyon Pharmaceuticals Inc. | Date: 2010-06-23

pharmaceutical and veterinary preparations; veterinary products; animal care products.

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