Hydromorphone
Clinical Need
Acute, moderate-to-severe pain affects 25 million in the United States. Approximately 50 million of the estimated 75 million Americans who live with severe pain suffer from chronic pain. Prescriptions for hydromorphone products have more than doubled in recent years.
Product Benefit
ITI’s hydromorphone nasal spray is in clinical development for acute, moderate-to-severe pain. We believe that the rapid onset, needle-free and highly accurate delivery of this opioid would be advantageous in a variety of clinical settings.
Compared with existing hydromorphone products, ITI’s nasal spray allows for exact dosing to improve therapeutic outcomes and predictability and, compared with oral forms, faster absorption. In addition, we believe that our unit dose, bi-dose and controlled multiple unit dose delivery devices, all of which have built-in control mechanisms, will improve compliance and limit abuse potential. Our hydromorphone product is initially targeted for trauma pain with the potential for expanded indications into areas of postoperative pain management, breakthrough cancer pain, and pain associated with invasive diagnostic procedures.
Development Status
We have submitted an IND to meet requirements for a 505(b)(2) NDA. In addition, we have conducted seven Phase I and two Phase II clinical studies for Hydromorphone HCl Nasal Spray in 185 completed subjects. Our studies have demonstrated rapid absorption of intranasal hydromorphone in healthy, adult volunteers, and bioavailability was almost 3-fold that of oral tablet dosage forms. No clinically significant unexpected adverse effects were reported, and the drug appeared to be safe and well tolerated by subjects. Additional information on these studies can be found in our publications.
ITI Publications
Coda BA, Rudy AC, Archer SM, Wermeling DP. Pharmacokinetics and Bioavailability of Single-Dose Intranasal Hydromorphone Hydrochloride in Healthy Volunteers. Anesth Analg 2003;97:117-123.
Edwards JE, Rudy AC, Wermeling DP, Desai N, McNamara PJ. Hydromorphone transfer into breast milk after intranasal administration. Pharmacotherapy 2003;23(2):153-158.
Davis GA, Rudy AC, Archer SM, Wermeling DP, McNamara PJ. Bioavailability and Pharmacokinetics of Intranasal Hydromorphone in Patients Experiencing Vasomotor Rhinitis. Clin Drug Invest 2004;24(11):633-639.
Davis GA, Rudy AC, Archer SM, Wermeling DP, McNamara PJ. Effect of fluticasone propionate nasal spray on bioavailability of intranasal hydromorphone hydrochloride in patients with allergic rhinitis. Pharmacotherapy 2004;24(1):26-32.
Rudy AC, Coda BA, Archer SM, Wermeling DP. A Multiple-Dose Phase 1 Study of Intranasal Hydromorphone Hydrochloride in Healthy Volunteers. Anesth Analg 2004; 99:1379-1386.
