Nexcyon Pharmaceuticals Inc.

Madison, WI, United States

Nexcyon Pharmaceuticals Inc.

Madison, WI, United States

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Savides M.C.,Ricerca Biosciences LLC | Pohland R.C.,Elanco Animal Health | Wilkie D.A.,Ohio State University | Abbott J.A.,Virginia Polytechnic Institute and State University | And 3 more authors.
Journal of Veterinary Pharmacology and Therapeutics | Year: 2012

Previous studies have demonstrated that a single, topical application of a novel, long-acting transdermal fentanyl solution provides analgesic fentanyl concentrations for at least 4days. The objective of this study was to describe the margin of safety following application at multiples of the therapeutic dose. Twenty-four laboratory dogs were administered a single placebo or 1×, 3×, or 5× multiple of the dose of 2.6mg/kg (50μL/kg) to the ventral abdominal skin and observed for 14days. Plasma fentanyl concentrations increased in proportion to dose. Adverse reactions in the 1× group were transient and included a low prevalence (≤33%) of mild sedation, reduced food intake, modest weight loss, and minimal reductions in heart rate and rectal temperature. Moderate to severe sedation emerged in the 3× and 5× groups, which was associated with a dose-limiting reduction in food and water intake, necessitating maintenance fluid replacement for the first 2days following application. Also observed in the higher-dose groups were an increased prevalence of abnormal stools and transient lens opacities. All abnormal health observations were completely resolved prior to necropsy on day 14, and there were no histological abnormalities identified. These data support the safe use of the 1× dose and describe the outcome of an overdose of up to 5× dose in the absence of opioid reversal. © 2012 Blackwell Publishing Ltd.


Freise K.J.,Nexcyon Pharmaceuticals Inc. | Savides M.C.,Ricerca Biosciences LLC | Riggs K.L.,Elanco Animal Health | Owens J.G.,Elanco Animal Health | And 2 more authors.
Journal of Veterinary Pharmacology and Therapeutics | Year: 2012

A novel, transdermal fentanyl solution (TFS) was developed that delivers sustained concentrations of fentanyl for days following a single application. The pharmacokinetics following a single topical dose was examined. Eighteen adult Beagle dogs were divided into three groups of six dogs (3M, 3F). Each group was administered a single dose of 1.3 (25), 2.6 (50), or 5.2mg/kg (100μL/kg) of TFS. The dose was applied to the clipped, ventral abdominal skin using a 1-mL tuberculin syringe. Immediately following dosing, collars were placed on each dog through 72h to prevent direct licking of the application site. Serial jugular venous blood samples were collected at 0 (predosing), 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 408, and 504h after dosing and assayed for plasma fentanyl concentration. Fentanyl was rapidly detected following application with a mean absorption lag time (tlag) of 0.333h in the 1.3mg/kg group and 0 in the other two groups. The mean Cmax increased with dose and were 2.28, 2.67, and 4.71ng/mL in the 1.3, 2.6 and 5.2mg/kg dose groups, respectively. Mean terminal half-lives were 53.7, 69.6, and 103h in the 1.3, 2.6, and 5.2mg/kg dose groups, respectively. The mean AUC0-LLOQ from lowest to highest dose groups were 157, 268, and 645ng·h/mL and were dose proportional with a R2 value of 0.9818. Adverse reactions were limited to the highest dose group and included sedation (four of six dogs) and decreased food and water intake (one dog). A dose of 2.6mg/kg (50μL/kg) is proposed for further development studies based on the lack of adverse events that were observed compared to the 5.2mg/kg group and a more rapid onset of action and longer duration of action compared to the 1.3mg/kg group. © 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. and Procyon Pharmaceuticals Inc. | Date: 2010-03-19

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


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.


PubMed | Nexcyon Pharmaceuticals Inc
Type: Journal Article | Journal: Journal of veterinary internal medicine | Year: 2014

Noninferiority trials are clinical studies designed to demonstrate that an investigational drug is at least as effective as an established treatment within a predetermined margin. They are conducted, in part, because of ethical concerns of administering a placebo to veterinary patients when an established effective treatment exists. The use of noninferiority trial designs has become more common in veterinary medicine with the increasing number of established veterinary therapeutics and the desire to eliminate potential pain or distress in a placebo-controlled study. Selecting the appropriate active control and an a priori noninferiority margin between the investigational and active control drug are unique and critical design factors for noninferiority studies. Without reliable historical knowledge of the disease response in the absence of treatment and of the response to the selected active control drug, proper design and interpretation of a noninferiority trial is not possible. Despite the appeal of conducting noninferiority trials to eliminate ethical concerns of placebo-controlled studies, there are real limitations and possible ethical conundrums associated with noninferiority trials. The consequences of incorrect study conclusions because of poor noninferiority trial design need careful attention. Alternative trial designs to typical noninferiority studies exist, but these too have limitations and must also be carefully considered.

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