– Program is on track for NDA submission in
4Q 2017 – – OLINVOTM to be the proprietary brand name
for oliceridine –– Company to host conference call and
webcast at 8:00 a.m. EST –
Trevena, Inc. (NASDAQ:TRVN) today announced positive top-line
results from its Phase 3 APOLLO-1 and APOLLO-2 pivotal efficacy
studies of oliceridine in moderate-to-severe acute pain following
bunionectomy and abdominoplasty, respectively. In both studies, all
dose regimens achieved their primary endpoint of statistically
greater analgesic efficacy than placebo, as measured by responder
rate. In addition, oliceridine showed dose-related trends of
improvements vs. morphine on numerous measures of respiratory
safety and gastrointestinal tolerability – both key unmet needs in
acute pain management.
“These data are exciting – they confirm earlier data, and show
an improved safety and tolerability profile of oliceridine compared
to morphine, with very similar results across the two studies,”
said Timothy Beard, M.D., FACS, Chair of Department of Surgery,
Bend Memorial Clinic, Oregon.
“We believe the data for all three dose regimens will support
FDA approval of IV oliceridine with a broad indication of
management of moderate-to-severe acute pain. These
successful trials cap a development program that has shown
consistent differentiation of oliceridine from morphine in multiple
clinical trials,” said Maxine Gowen, Ph.D., chief executive
officer. “We look forward to submitting a new drug
application with the goal of bringing this innovative product to
patients.”
Both APOLLO trials were Phase 3, multicenter, randomized,
double-blind, placebo- and active-controlled studies of
oliceridine. The primary objective of each study was to
evaluate the analgesic efficacy of oliceridine compared to placebo.
Secondary endpoints included comparisons of efficacy, safety, and
tolerability of oliceridine to morphine. Both studies
included multiple measurements of nausea and vomiting, which occur
in approximately 30% of postoperative patients and increase costs
to hospitals, as well as multiple measures of respiratory safety,
which can pose serious and costly risks to patient safety.
Results of APOLLO-1 (bunionectomy)
- All three oliceridine regimens (0.1 mg, 0.35 mg, and 0.5 mg
on-demand doses) achieved the primary endpoint with statistically
superior responder rates compared to placebo at 48 hours
(p<0.0001, adjusted for multiplicity).
- The 0.35 mg and 0.5 mg oliceridine dose regimens demonstrated
efficacy comparable to morphine at 48 hours based on responder rate
(both doses p<0.005 for non-inferiority to morphine). Both
doses were also comparable to morphine for rates of rescue
analgesic use.
- Following the 1.5 mg initial loading dose, all oliceridine
regimens demonstrated rapid onset with statistically significant
efficacy by 5 minutes (p<0.05).
- Oliceridine exhibited a dose-related trend of improved
respiratory safety burden in all three oliceridine dose regimens
(p<0.05 for the 0.1 mg regimen vs. morphine). Consistent
with this, in all dose regimens oliceridine showed dose-related
trends of reduced prevalence of oxygen desaturation (O2 < 90%)
and lower prevalence of supplemental oxygen use (p<0.05 for the
0.1 mg regimen vs. morphine for both measures).
- Oliceridine exhibited a dose-related trend of less antiemetic
use compared to morphine (p<0.05 for all oliceridine regimens
vs. morphine). Consistent with this, oliceridine showed dose
related trends of lower prevalence of nausea and vomiting in all
three oliceridine regimens (p<0.05 for the 0.1 mg regimen vs.
morphine).
Results of APOLLO-2 (abdominoplasty)
- All three oliceridine dose regimens achieved the primary
endpoint with statistically superior responder rates compared to
placebo (adjusted p<0.05 for the 0.1 mg regimen; adjusted
p<0.001 for the 0.35 mg and 0.5 mg regimens).
- The 0.35 mg and 0.5 mg oliceridine dose regimens demonstrated
efficacy comparable to morphine at 24 hours based on responder rate
(p<0.05 for non-inferiority of the 0.35 mg regimen vs.
morphine). Both doses were also comparable to morphine for
rates of rescue analgesic use.
- Following the 1.5 mg initial loading dose, all oliceridine
regimens demonstrated rapid onset with statistically significant
efficacy by 5 to 15 minutes (p<0.05).
- Oliceridine showed a dose-related trend of improved respiratory
safety burden in all three oliceridine dose regimens (p<0.05 for
the 0.1 mg regimen vs. morphine). Consistent with this, for
all dose regimens oliceridine showed dose-related trends of reduced
prevalence of oxygen desaturation (O2 < 90%) and lower
prevalence of supplemental oxygen use (p<0.05 for the 0.1 mg
regimen vs. morphine for both measures).
- Oliceridine showed a dose-related trend of less antiemetic use
than morphine for all three oliceridine regimens (p<0.05 for the
0.1 mg oliceridine regimen vs. morphine). Consistent with this,
oliceridine showed dose-related trends of lower prevalence of
nausea and vomiting (p<0.05 for the 0.1 mg regimen vs. morphine
for both nausea and vomiting; p<0.05 for the 0.35 mg regimen vs.
morphine for vomiting).
In both studies, oliceridine was generally safe and
well-tolerated. The most common drug-related adverse events
were nausea, vomiting, headache, and dizziness.
Full results will be presented at a future scientific conference
or in a peer-reviewed publication.
Oliceridine program update
The Company also announced that patient enrollment for the Phase
3 ATHENA multi-procedure safety study remains on track, with over
400 patients treated with oliceridine and no apparent off-target or
unexpected adverse effects to date. In addition, a recently
completed renal impairment study suggests that no dose adjustment
will be required in renally impaired patients, and a metabolism
study showed no evidence of active metabolites. These data
distinguish oliceridine from conventional opioids like morphine and
hydromorphone and support ease of administration for oliceridine –
particularly in at-risk patients for whom safe opioid titration can
be challenging. All additional clinical, non-clinical, and
manufacturing activities remain on track to support an NDA
submission in the fourth quarter of this year.
The Company also announced that the U.S. Food & Drug
Administration has conditionally accepted OLINVOTM as the
proprietary brand name for oliceridine.
Conference call and webcast
Date: Tuesday, February 21, 2017
Time: 8:00 a.m. (EST)
Telephone Access: (855) 465-0180
International: (484) 756-4313
Conference ID: 75705243
To access the live audio webcast of the presentation and the
slides, please visit the Investor section of the
Company's website. The webcast will be available for replay for 30
days.
About APOLLO-1 and APOLLO-2
The APOLLO-1 and APOLLO-2 studies were both Phase 3,
multicenter, randomized, double-blind, placebo- and
active-controlled studies of oliceridine. APOLLO-1 and APOLLO-2
evaluated oliceridine’s efficacy in patients for 48 hours following
bunionectomy and 24 hours following abdominoplasty, respectively.
During the study period, a loading dose of placebo, morphine (4
mg), or oliceridine (1.5 mg) was administered first, and then
patients used a patient controlled analgesia (PCA) button to dose
themselves as often as every 6 minutes with the same study drug: 1
mg morphine or 0.1 mg, 0.35 mg, or 0.5 mg oliceridine. If PCA
dosing was inadequate to control pain, patients could request
supplemental study medication (0.75 mg oliceridine or 2 mg
morphine, no more than once an hour). If the study medication
regimen did not adequately manage pain, patients could opt for an
NSAID rescue analgesic. Placebo loading, demand, and supplemental
doses were volume-matched.
All endpoints were the same in both studies. Efficacy was
measured by a responder analysis, which defined a responder as a
patient who experienced at least a 30% reduction in their sum of
pain intensity difference (SPID) at the end of the treatment period
without either early discontinuation (for lack of efficacy or
safety/tolerability) or use of rescue medication. Non-inferiority
to morphine and superiority to morphine were key secondary
endpoints. Respiratory safety events were defined as clinically
relevant worsening of respiratory status (e.g., oxygen saturation,
respiratory rate, or sedation). The product of the frequency
and conditional duration of these events was reported as
respiratory safety burden, a key secondary endpoint.
Additional measures of respiratory safety included prevalence of
oxygen saturation less than 90% and prevalence of supplemental
oxygen use. Measures of gastrointestinal tolerability
included use of rescue antiemetics, vomiting, and spontaneously
reported nausea.
About OLINVOTM (oliceridine injection)
OLINVOTM (oliceridine injection), Trevena’s lead product
candidate, is a next generation IV analgesic in Phase 3 development
for the management of moderate-to-severe acute pain in the hospital
and similar settings and has been granted Breakthrough Therapy
designation by the U.S. Food and Drug Administration (FDA). OLINVO
was specifically designed to improve conventional opioid
pharmacology to deliver the pain-reducing potential of an opioid
but with fewer associated adverse effects. In Phase 2 and Phase 3
clinical trials, OLINVO provided rapid and powerful analgesic
efficacy while demonstrating a wider therapeutic window compared to
morphine, suggesting it may be highly effective and well-tolerated
for patients in need of strong analgesia. OLINVO is an
investigational product and has not been approved by the FDA or any
other regulatory agency. The Company expects OLINVO to be a
Schedule II controlled substance.
About Trevena
Trevena, Inc. is a biopharmaceutical company developing
innovative therapies based on breakthrough science to benefit
patients and healthcare providers confronting serious medical
conditions. The Company has discovered four novel and
differentiated drug candidates, including oliceridine. Trevena also
has discovered TRV250, in preclinical development for the treatment
of migraine, and TRV734 for pain. The Company maintains an early
stage portfolio of drug discovery programs.
Cautionary note on forward looking
statements
Any statements in this press release about future expectations,
plans and prospects for the Company, including statements about the
Company’s strategy, future operations, clinical development of its
therapeutic candidates, plans for potential future product
candidates and other statements containing the words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “suggest,” “target,” “potential,” “will,”
“would,” “could,” “should,” “continue,” and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including: the
status, timing, costs, results and interpretation of the Company’s
clinical trials, including the interpretation of the top-line
results from the APOLLO trials, the consistency of such results
between the two trials and previous clinical trials, and the
expected timing of the NDA submission for oliceridine; the
uncertainties inherent in conducting clinical trials, including
whether top-line results from the APOLLO trials will be consistent
with the full results of the trials, once available, or adverse
events seen to date in the ATHENA safety study will be consistent
with any future adverse events; expectations for regulatory
approvals, including whether the Phase 3 data will support FDA
approval of oliceridine for the management of moderate-to-severe
pain; availability of funding sufficient for the Company’s
foreseeable and unforeseeable operating expenses and capital
expenditure requirements; uncertainties related to the Company’s
intellectual property; other matters that could affect the
availability or commercial potential of the Company’s therapeutic
candidates, including whether physicians, patients, and payors will
conclude that the oliceridine development program has shown
consistent differentiation from morphine across multiple clinical
trials; and other factors discussed in the Risk Factors set forth
in the Company’s Annual Report on Form 10-K and Quarterly Reports
on Form 10-Q filed with the Securities and Exchange Commission
(SEC) and in other filings the Company makes with the SEC from time
to time. In addition, the forward-looking statements included in
this press release represent the Company’s views only as of the
date hereof. The Company anticipates that subsequent events and
developments may cause the Company’s views to change. However,
while the Company may elect to update these forward-looking
statements at some point in the future, it specifically disclaims
any obligation to do so, except as may be required by law.
Contacts
Trevena, Inc.
Investors:
Jonathan Violin, Ph.D.
Sr. Director, Investor Relations
610-354-8840 x231
jviolin@trevena.com
or
Media:
Public Relations
PR@trevena.com
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