Daniel Wermeling - Pharm.D., FASHP, FCCP
Dr. Wermeling’s primary area of research involves formal drug development in an academic setting sponsored by pharmaceutical industry, University/faculty sponsorship, or of products of his own design. A goal for this development process, particularly for UK-held intellectual property, is to evolve the development into independent businesses that form in the Lexington community. Specific development programs include the design, formulation, manufacturing and clinical testing of drugs and delivery systems designed for intranasal drug administration leading toward a new drug application and FDA approval for marketing.
- Kentucky Colonel (2006)
- Kentucky Research Pharmacist of the Year (1988)
- Module Leader, PHR 946 Advanced Therapeutics I - Pain Management Module
- Coordinator, PHR 564 Introduction to FDA and Drug Development Process
- Coordinator, PHR 764 Drug Development Regulation and Clinical Research
- Wermeling DP, Clinch TC, Rudy AC, Dreitlein D, Sumer S, LaCouture P. A Multicenter, Open-Label, Dose-Ranging Trial of Intranasal Hydromorphone for Managing Acute Pain from Traumatic Injury. Accepted, in press, The Journal of Pain 2009.
- Wermeling DP. Intranasal Delivery of Antiepileptic Medications for the Treatment of Seizures. Neurotherapeutics 2009 Apr; 6:(2) 352-358.
- Wermeling DP, Record KE, Archer SM, Rudy AC. A Pharmacokinetic and Pharmacodynamic Study, in Healthy Volunteers, of a Rapidly Absorbed Intranasal Midazolam Formulation. Epilepsy Research 2009 83:124-132.
- Cheang Kl, Ott C, Garnber S, Campbell H, Hansen L, Ma Q, Nazeri E, Gunning K, Wermeling DP. Clinical Research in Special Populations: ACCP White Paper. Pharmacotherapy 2008 28(9) 1203-1206.
- Lacotoure P, Dreitlein D, Suner S, Hefti F, Clinch T, Pike D, Wermeling D. A Pharmacokinetic Profile in Intranasal Hydromorphone in Emergeny Room Trauma Patients. The Journal of Pain 2008 9(4) suppl (2) 36-41.
- Miller JL, Ashford W, Archer SM, Wermeling DP. Comparison of Intranasal Administration of Haloperidol with Intravenous and Intramuscular Administration: A Pilot Pharmacokinetic Study. Pharmacotherapy July 2008; 28(7):875-882.
- Wermeling DP, Banks SL, Hudson DA, Gill HS, Gupta J, Prausnitz M, Stinchcomb AL. Microneedles Permit Transdermal Delivery of a Skin-Impermeant Medication to Humans. PNAS 2008 Feb; 105(6): 2058-63.
- Pharmacokinetics and Pharmacodynamics of a New Intranasal Midazolam Formulation in Healthy Volunteers. Wermeling DP, Record K, Kelly TH, Archer SM, Clinch T, Rudy AC. Anesthesia and Analgesia. In press, 2006
- Ziconotide Infusion for Severe Chronic Pain: A Case Series of Patients with Neuropathic Pain. Wermeling DP, Berger JR., Pharmacotherapy 2006: 26 (3), 395-402.
- Pharmacokinetics, Bioequivalence and Dose Reproducibility of Intranasal Butorphanol After Administration with Two Different Nasal Spray Pumps. Wermeling DP, Miller JL, Archer SM, Rayens MK, Rudy AC., Journal of Clinical Pharmacology August 2005; 45 (8): 969-73.
- A Review of Ziconotide, an N-Type Calcium Channel Antagonist, Delivered by Intrathecal Adminsitration for the Treatment of Chronic Pain. Wermeling, DP. Pharmacotherapy 2005: 25 (8) 1084-94.
- A Randomized, Double-Blind, Parallel-Group Study Comparing the Analgesic Effects of Intranasal Butorphanol Tartrate to Placebo, Using a Unit Dose Nasal Spray Device, in the Dental Impaction Pain Model. Wermeling, DP, Grant GM, Lee A, Alexander N, Rudy AC. Clinical Therapeutics 2005; 27 (4): 430-440.
- Bioavailability of Intranasal Butorphanol Administered from a Single-dose Sprayer. Davis GA, Rudy A, Archer SM, Wermeling, DP. American Journal of Health System Pharmacy 2005 62 (1): 48-53
- Intranasal Delivery of recombinant human parathyroid hormone hPTH 1-34, teripartitide in rats. Agu R, Valiveti S, earles DC, Klausner M, Hayden PJ, Wermeling DP, Stinchcomb AL. Endocrine Research 2004; 30 (3), 455-467
- "Pharmacokinetics of Butorphanol Tartrate Administered from Single-Dose Intranasal Sprayer", Davis GA, Rudy AC, Archer SM, Wermeling DP, American Journal of Health-Systems Pharmacists 2004;61:261-266
- "Effect of Fluticasone Propionate Nasal Spray on Bioavailability of Intranasal Hydromorphone Hydrochloride in Patients with Allergic Rhinitis", Davis GA, Rudy AC, Archer SM, Wermeling DP, McNamara PJ, Pharmacotherapy 2004;24(1):26-32
- "Pharmacokinetics and Pharmacodynamics of Intrathecal Ziconotide in Chronic Pain Patients", Wermeling DP, Drass M, Ellis D, Mayo M, McGuire D, O'Connell D, Hale V, Chao S, The Journal of Clinical Pharmacology 2003;43:624-636
- "Hydromorphone Transfer Into Breast Milk After Intranasal Administration", Edwards JE, Rudy AC, Wermeling DP, Desai N, McNamara PJ, Pharmacotherapy 2003;23(2):153-158
- "Pharmacokinetics and Bioavailability of Single-Dose Intranasal Hydromorphone Hydrochloride in Healthy Volunteers", Coda BA, Rudy AC, Archer SM, Wermeling DP, Anesthesia and Analgesia 2003;97:117-123
- Lacotoure P, Dreitlein D, Suner S, Hefti F, Clinch T, Pike D, Wermeling D. A Pharmacokinetic Profile in Intranasal Hydromorphone in Emergency Room Trauma Patients. Meeting of the American Pain Society, Tampa FL, May 9, 2008.
- Lacotoure P, Dreitlein D, Suner S, Hefti F, Clinch T, Pike D, Wermeling D. Acute Pain Management Research in the Emergency Department – Considerations for Model Development. 27th Meeting of the American Pain Society, Tampa FL, May 9, 2008.
- Harris W, Kuhn R, Spilling C, Wermeling D, Yokel R, Zhan CG. An in Line Filter to Remove Aluminum from Intravenous Feeding Solutions. 4th Kentucky Innovation and Enterprise Conference, Louisville, KY, April 11, 2008.
- Babalonis S, Wermeling DP, Joseph JE, Martin CA, Kelly TH. Behavioral and cardiovascular effects o intranasal d-amphetamine in humans. 70th Annual Scientific Meeting, College on Problems with Drug Dependence, San Juan, Puerto Rico, February, 2008
- Banks SA, Wermeling DP, Hudson DA, Gill HS, Prausnitz M, Stinchcomb AS. Microneedle Enhanced Skin Permeation of Naltrexone Hydrochloride in Human Volunteers. American Association of Pharmaceutical Scientists Annual Meeting, Nashville, TN, November, 2007.
- Wermeling DP, Banks SA, Hudson DA, Gill HS, Prausnitz M, Stinchcomb AS. Successful Transdermal Delivery of a Skin Impermeable Molecule Using Microneedles. American College of Clinical Pharmacy, Denver, CO, October 15, 2007.
- Wermeling DP. Successful transdermal delivery of a skin impermeable molecule using microneedles. Poster session presented at: American College of Clinical Pharmacy (ACCP) Annual Conference; 2007 October 15; Denver, CO.
- ACCP Frontiers Award - "fMRI Imaged Neuroactivation and Craving in Alcoholics is Modulated by Ondansetron." American College of Clinical Pharmacy, $30,000, August 2007. Role: Principal Investigator.
- NIH MO1RR02602 - Priority Score 150- Alcohol Related fMRI Imaged Neuroactivation and Craving: Part A Imaging Validation; Part B Medication Administration. October 2007, Role: Principal Investigator.
- NIH - R41HD055009-01, A Device Containing Immobilized Chelator to Remove Aluminum in TPN Solutions. October 2007, 2.5% effort, Role: Subinvestigator.
- 1R41AA016500-01, Priority Score 161, Nasal Delivery of Naltrexone for the Treatment of Alcoholism: Role: Principal Investigator 10% effort. National Institute on Alcoholism and Alcohol Abuse, $ 100,000, June 2006.
- The Effects of Intranasal Corticotropin Releasing Hormone on Cortical and Subcortical Information Processing. PI Royce Lee, M.D. $ 1000 per year for 2 years. Role - Co-Investigator on grant from Brain Foundation and subcontract from University of Illinois Chicago. April 2006.
- A Pilot Study of the Effect of Intranasal Corticotropin-Releasing Hormone on Emotion Processing in Remitted Depression. PI: Royce Lee, M.D. $ 30,000 over 2 years. Role - Co-investigator $ 3000/yr. NARSAD Foundation and University of Illinois subcontract. April 2006.
- Microneedle Assisted Naltrexone Hydrochloride Transdermal Delivery for the Treatment of Addictions. Role: Principal Investigator. UK Internal Competition. Pilot Research Project $17,250. April 2006.
- A Double Blind, Randomized, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of GW572016 in Healthy Volunteers, Glaxo EFG10002 (Co-Principal Investigator) $671,627 2000 .
- ITI Infrastructure, Project #4 (DPEU). Inhalation Technology, Inc. (Principal Investigator) $2,177,587 2000-1 .
- A Single-Dose, Open-Label, Three Way Crossover, Randomized, Pilot Bioavailability Study of Lorazepam Comparing Intranasal Administration to Intravenous and Intramuscular Administration in Healthy Human Volunteers, Inhalation Technology, Inc. (Principal Investigator) $116,174 2000.
- A Double Blind, Randomized, Placebo-Controlled, Crossover Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Oral Escalating Doses of GW572016 Ditosylate Monohydrate in Healthy Volunteers, Glaxo EFG10001(Co-Principal Investigator) $379,970 1999.
- "A Single and Multiple Dose Pharmacokinetic Study of 2.0 mg Intranasal Hydromorphone Hydrochloride in Healthy Volunteers, Inhalation Technology, Inc. (Principal Investigator) $160,896 1998.