Pain and Neurology
KZE has extensive experience in regulatory and manuscript writing for neurological disorders (e.g., epilepsy, multiple sclerosis, muscle spasticity, and hepatic encephalopathy) and for pain management in migraine.
Medical Writing Products
Abstracts, posters and slide sets
Medical information letters
Clinical trial study reports and protocols,
IND and NDA CTD components
Three-year publication plan for a novel formulation of an NSAID for acute pain management in the emergency department and post-surgical setting, and for use in acute treatment of migraine.
Publication planning for novel formulations of NSAIDs combined with proton pump inhibitors.
Environmental Landscape analysis (key themes and issues impacting on development of a publication and communication plan) for a novel opiate agonist for management of IBS pain.
Message mapping and gap-analysis for a novel formulation of an NSAID for acute pain management in the emergency department and post-surgical setting and for use in acute treatment of migraine.
Competitive analysis (press release activity, publications and meeting abstracts, and other publicly available information such as company web sites to identify product positioning, key milestones and communication strategies for acute pain management products in development and marketed.
Bibliography: Sample Publications and Abstracts
R Bullingham, T Juan. Comparison of Intranasal Ketorolac Pharmacokinetics in Younger and Older Adults. Drugs and Aging, 29(11):899-904. 2012.
R Bacon, S Newman S, L Rankin, et al. Pulmonary and Nasal Deposition of Ketorolac Tromethamine Solution (SPRIX) Following Intranasal Administration. Int. J. Pharmaceutics, 431(1-2):39-44, 2012.
V Pfaffenrath, E. Fenzl, D Bregman, M Färkkila, Intranasal ketorolac tromethamine (SPRIXÒ) containing 6% of lidocaine (ROX-828) for acute treatment of migraine: safety and efficacy data from a Phase II clinical trial. Cephalalgia, 32(10):766-77, 2012.
N Singla, S Singla, HS Minkowitz et al. Intranasal ketorolac for acute postoperative pain: a phase 3, double-blind, randomized study in abdominal surgery patients. CMRO 26(8):1915-23, 2010.
JR Fricke, L Bynum. Intranasal Ketorolac (ROX-888) for the Treatment of Pain Following Dental Impaction Surgery. J Oral Maxillofacial Surg, 68(5):1025-31, 2010.
C Brown, J Moodie, E Bisley, L Bynum Intranasal Ketorolac (ROX-888) for Postoperative Pain: A Phase 3, Double-Blind, Randomized Study Pain Med 10(6):1106-14, 2009.
JR Fricke, L Bynum. Intranasal Ketorolac (ROX-888) for the Treatment of Pain Following Dental Impaction Surgery. Abstract presented at the Am Assoc Oral-Maxillary Surgeons, 2007.
C Brown, J Moodie, E Bisley, L Bynum. Intranasal Ketorolac (ROX-888) for Postoperative Pain: A Phase 3, Double-blind, Randomized Study. Abstract presented at the Am Soc Anesthesiology, 2007.