Track III: New & Late Breaking Pipeline Medications

Course Description

The purpose of the Pipeline session is to present the very latest information about new CNS compounds to attendees at the CPNP Annual Meeting with the goal being that attendees will learn about the most promising agents in the specialty drug pipeline.

4:30-4:32: Session and Speaker Introduction
Jerry Overman, PharmD, BCPP

4:32-5:52 p.m.: Efficacy and Safety of LY2951742 in a Phase IIB, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study
Authors: Stauffer VL1,Skljarevski V1, Zhang Q1, Ferguson MB1, Oakes TM1, Martinez JM1, Johnson KW1, Schacht AL1, Due MR1, Dodick DW2
1Eli Lilly and Company, Indianapolis, IN; 2Mayo Clinic, Phoenix, AZ

1Eli Lilly and Company, Indianapolis, IN; 2Mayo Clinic, Phoenix, AZ

Speaker: Virginia Stauffer, PharmD

4:52-4:53 p.m.: Speaker Introduction
Jerry Overman, PharmD, BCPP

4:53-5:13 p.m.: Efficacy and Safety of Intravenous Esketamine in Patients with Treatment-Resistant Depression: A Double-Blind, Double-Randomization, Placebo-Controlled Phase 2a Study
Authors: Jaskaran B. Singh, Maggie Fedgchin, Ella Daly, Liwen Xi, Caroline Melman, Geert De Bruecker, Andre Tadic, Pascal Sienaert, Frank Wiegand, Husseini Manji, Wayne C. Drevets, and Luc Van Nueten
Speaker: Dean Najarian, PharmD, BCPP

5:13-5:15 p.m.: Session Conclusion
Jerry Overman, PharmD, BCPP

Learning Objectives

Efficacy and Safety of Intravenous Esketamine in Patients with Treatment-Resistant Depression: A Double-Blind, Double-Randomization, Placebo-Controlled Phase 2a Study

  1. To understand a novel mechanism of action for rapid antidepressant effect.
  2. To evaluate the safety, efficacy and dose response of intravenous esketamine in treatment resistant depression (TRD).

Efficacy and Safety of LY2951742 in a Phase IIB, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study

  1. To understand the role of a humanized monoclonal antibody to calcitonin gene-related peptide in the prevention of episodic migraine headache.
  2. To understand dose selection of LY2957142 for Phase III development for the prevention of episodic migraine headache.

Target Audience

This course is designed for pharmacists, nurse practitioners or other healthcare professionals involved in the comprehensive medication management of psychiatric and/or neurological patients.

Faculty

Virginia Stauffer, PharmD
Dean Najarian, PharmD, BCPP
View biographical information

Virginia Stauffer, PharmD
Senior Clinical Research Scientist
Eli Lilly & Company
Indianapolis, IN

Dean Najarian, PharmD, BCPP
Medical Affairs Liaison
Janssen Scientific Affairs
Wrentham, MA

Course Requirements

To receive ACPE credit for this session, you must:

  • Register for this course.
  • Review the full content of the activity and reflect upon its teachings.
  • Complete the evaluation at the end of the activity.
  • Provide the necessary details in your profile to ensure correct reporting by AAPP to CPE Monitor.

Continuing Education Credit and Disclosures

Activity Date: 04/19/2016
ACPE Contact Hours: 0.75
ACPE Number: 0284-0000-16-019-L01-P (Knowledge)
Nursing Credit Reminder: Note that ACPE credit is accepted for ANCC Certification Renewal and AANPCB advanced practice provider content. For specific questions related to your organization's acceptance of ACPE continuing education units, please contact your organization directly.

ACPEThe College of Psychiatric and Neurologic Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This self-study course provides 0.75 contact hours (0.075 CEUs) of knowledge-based continuing education credit from CPNP approved programming. The ACPE universal program number assigned to this course is 0284-0000-16-019-L01-P (.75 contact hours).

View AAPP's Privacy Policy

AAPP owns the copyright, is licensed or has received permissions for use of, or is otherwise permitted to use copyrighted materials within any CPE activity. Authors and speakers are required to obtain necessary copyright permissions for content in CPE activities. AAPP complies with copyright laws and regulations.

Questions? Contact AAPP.

View planning committee disclosures

2016 CPNP Program Committee
Disclosures of Interest

Jolene R. Bostwick, PharmD, BCPP, BCPS
Ann Arbor, MI
Employment: University of Michigan Health System - Clinical Pharmacist in Psychiatry, University of Michigan College of Pharmacy - Clinical Assistant Professor

Sheila R. Botts, PharmD, BCPP, FCCP
Aurora, CO
Employment: Kaiser Permanente Colorado
Educational Grants, Research Grants or Contracts: Kaiser Permanente Center for Safety and Effectiveness
Non-Financial Interests: Board of Pharmacetical Specialties Psychiatric Pharmacy Specialty Council

Jessica L. Brennan, PharmD, BCPP
Pittsburgh, PA
Employment: Western Psychiatric Institute and Clinic of UPMC, Psychiatric Clinical Pharmacist, Dual Diagnosis
Non-Financial Interests: Adjunct Professor of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy

Austin R. Campbell, PharmD, BCPP
Columbia, MO
No Relevant Financial Relationships to Disclose

Jack J. Chen, PharmD, BCPS, CGP, FASCP, FCCP
Fullerton, CA
Employment: Marshall B Ketchum University
External Consultant Activities, Advisory Panels, Speakers Bureaus, etc.: Ipsen - Consultant
Educational Grants, Research Grants or Contracts: Lundbeck
Non-Financial Interests: Faculty Panel Chair - ACCP BCACP neuropsych module

Julie L. Cunningham, PharmD, BCPP
Rochester, MN
Employment: Mayo Medical Center, Pharmacotherapy Coordinator for Neurology, psychiatry, rehabilitation and emergency department areas
Bri Englett, PharmD, BCPP
Phoenix, AZ
No Relevant Financial Relationships to Disclose

Kelly N. Gable, PharmD, BCPP
Edwardsville, IL
Employment: Associate Professor, Department of Pharmacy Practice, SIUE School of Pharmacy
External Consultant Activities, Advisory Panels, Speakers Bureaus, etc.: Places for People, Psychiatric Clinical Pharmacist

Lisa W. Goldstone, PharmD, MS, BCPS, BCPP
Program Committee Chair

Tucson, AZ
Employment: The University of Arizona, Assistant Professor, Banner University Medical Center - South, Assistant Professor/Psychiatric Pharmacist

Deanna L. Kelly, PharmD, BCPP
Baltimore, MD
Employment: University of Maryland School of Medicine
Educational Grants, Research Grants or Contracts: XOMA, Lundbeck

Monica Mathys, PharmD, BCPP
Dallas, TX
Employment: Texas Tech Health Sciences Center School of Pharmacy, VA North Texas Healthcare System
Rosana C. Oliveira, PharmD, BCPS, BCPP
San Antonio, TX
Employment: South Texas Veterans Health Care System
Gerald P. Overman, PharmD, BCPP
Bethesda, MD
No Relevant Financial Relationships to Disclose
Thomas R. Smith, PharmD
Fort Wayne, IN
Employment: Manchester University College of Pharmacy, Assistant Professor of Pharmacy Practice
Kristyn Straw, PharmD, BCPP
Tucson, AZ
Employment: Southern Arizona VA Health Care Systems; Mental Health Pharmacist

Christopher Thomas, PharmD, BCPP, BCPS
Chillicothe, OH
Employment: Chillicothe VAMC (Clinical Pharmacist and Residency Program Director), Wife: Omnicare (Consultant/Clinical Pharmacist)
Financial Interests: Omnicare, Pfizer, Merck, Lilly, Glaxo, Proctor and Gamble Stock
Non-Financial Interests: CPNP: Board of Directors (Treasurer, President-elect starting 7/15)

Daina Wells, PharmD, BCPP, BCPS
San Francisco, CA
Employment: Academic Detailing Program, VACO PBM, National Program Manager

All relevant relationships have been mitigated.

View study author disclosures

Stauffer VL, Skljarevski V, Ferguson MB, Johnson KW, Martinez JM, Oakes TM, Schacht AL, and Zhang Q are full-time employees of Eli Lilly and Company and/or one of its subsidiaries, and are stockholders. Due MR is a full-time employee of Eli Lilly and Company and/or one of its subsidiaries. David W. Dodick M.D., has served on advisory boards and/or has consulted for Allergan, Amgen, Alder, Arteaus, Pfizer, Colucid, Merck, ENeura, NuPathe, Eli Lilly and Company, Autonomic Technologies, Ethicon J&J, Zogenix, Supernus, Labrys, Boston Scientific, Medtronic, St Jude, Bristol Myers Squibb, Lundbeck, Impax, MAP, Electrocore, Tonix, Novartis, Teva, Alcobra. Dr. Dodick has received funding for travel, speaking, editorial activities or royalty payments from: IntraMed, SAGE Publishing, Sun Pharma, Allergan, Oxford University Press, American Academy of Neurology, West Virginia University Foundation; Canadian Headache Society; Healthlogix, Wiley, Universal Meeting Management, WebMD, UptoDate, Oregon Health Science Center, Starr Clinical, Decision Resources, Synergy.

All relevant relationships have been mitigated.

View disclaimer and disclosure of off-label use

Off-Label Use: This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA (see faculty information). The opinions expressed in the educational activity do not necessarily represent the views of AAPP and any educational partners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Presentation-Specific Disclosure: Dean Najarian's presentation will include discussion of off-label, experimental, and/or investigational use of drugs or devices: Esketamine derivatives. Virginia Stauffer's presentation will include discussion of off-label, experimental, and/or investigational use of drugs or devices: LY CGRP monoclonal antibody for migraine prevention.

View fair balance and integrity statement

It is the policy of AAPP to ensure independence, balance, objectivity, scientific rigor, and integrity in continuing education activities. Those involved in the development of this continuing education activity have made all reasonable efforts to ensure that information contained herein is accurate in accordance with the latest available scientific knowledge at the time of accreditation of this continuing education activity. Information regarding drugs (e.g., their administration, dosages, contraindications, adverse reactions, interactions, special warnings, and precautions) and drug delivery systems is subject to change, however, and the reader is advised to check the manufacturer’s package insert for information concerning recommended dosage and potential problems or cautions prior to dispensing or administering the drug or using the drug delivery systems.

Fair balance is achieved through ongoing and thorough review of all materials produced by faculty, and all educational and advertising materials produced by supporting organizations, prior to educational offerings. Approval of credit for this continuing education activity does not imply endorsement by AAPP for any product or manufacturer identified.