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Hylenex

Phase 3

Pain | Small molecule | Pain |Halozyme Therapeutics, Inc.|Last Updated: Jan 14, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00593281INFUSE Morphine StudyPHASE3 COMPLETED 13Jan 1, 2006Oct 1, 2006Jan 14, 20082 United States
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Study Endpoints
Primary Endpoints
• Determine the Tmax and other pharmacokinetic parameters of morphine injected subcutaneously with HYLENEX compared to without HYLENEX and injected intravenously
29 days
Secondary Endpoints
Compare the safety and tolerability of these three methods of injections of morphine
29 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1NO_INTERVENTIONIV Morphine
2EXPERIMENTALSC Morphine with Hylenex
3ACTIVE_COMPARATORSC Morphine with Saline
Interventions
NameTypeDescription
HylenexDRUGAdd Hylenex to SC injection of Morphine
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Males or females at least 18 years of age who are patients of San Diego Hospice \& Palliative Care or recruited through San Diego Hospice \& Palliative Care or the UCSD Center for Pain and Palliative Medicine. 2. During the treatment days of the study, on opioid therapy other...

Countries:United States
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