Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced that its poster, to be presented at the
International Society for Anaesthetic Pharmacology (“ISAP”) 32nd
Annual Meeting, has been awarded first prize. The presentation,
entitled “Pharmacokinetics and pharmacodynamics of remimazolam for
procedural sedation in children and adolescents,” summarizes the
results of the modeling of the remimazolam pharmacokinetic data by
the University of Groningen Medical Center (“UMCG”). The annual
ISAP meeting is being held on October 13, 2023, the first day of
the American Society of Anesthesiologists (“ASA”) Annual Meeting,
in San Francisco, CA.
The model-informed drug development project was conceived by
Eagle and executed in collaboration with UMCG to determine the
appropriate dosing scheme for remimazolam in pediatric patients, as
agreed upon with the U.S. Food and Drug Administration (“FDA”).
“It is an honor to receive first-prize recognition for this
important analysis,” stated Valentin Curt, MD, Senior Vice
President, Clinical Drug Development and Interim Chief Medical
Officer at Eagle Pharmaceuticals. “We are pleased to be part of
this dynamic scientific community and grateful for this
acknowledgement as we share in the ISAP’s mission to promote the
study of anesthetic pharmacology.”
Details of the poster presentation are as follows:
Title: |
Pharmacokinetics and pharmacodynamics of remimazolam for procedural
sedation in children and adolescents |
Date: |
Friday, October 13, 2023 |
Time: |
3:00pm – 4:30pm PT |
Location: |
Hilton Union Square, San Francisco |
Remimazolam, a short-acting benzodiazepine, is currently not
approved for use in patients under 18 years of age. As part of the
pediatric study plan agreed upon with the FDA, a clinical trial was
initiated in 2021 to assess the efficacy and safety of IV
remimazolam in inducing and maintaining appropriate sedation levels
in pediatric patients undergoing diagnostic and/or therapeutic
procedures. This poster presentation reports on an interim analysis
of the pharmacokinetics and pharmacodynamics of remimazolam and a
subsequent model-based optimization of the dosing regimen that was
studied in the trial.
Used currently only in adults, Byfavo (remimazolam) is a rapid
onset/offset procedural sedative with an established safety and
efficacy profile and a broad label.
About BYFAVO® (remimazolam)1
Injection: Byfavo is a novel benzodiazepine
approved by the U.S. Food and Drug Administration in July 2020 for
sedation in patients undergoing procedures less than 30 minutes in
duration. Esterase metabolism and biotransformation to an inactive
metabolite provide unique pharmacokinetic differences compared with
other benzodiazepines. In May, the Centers for Medicare &
Medicaid Services (“CMS”) established a unique, product-specific
billing code for Byfavo (remimazolam for injection), which became
effective on July 1, 2023. For more information about Byfavo, visit
byfavo.com.About Eagle Pharmaceuticals, Inc. Eagle
is a fully integrated pharmaceutical company with research and
development, clinical, manufacturing and commercial expertise.
Eagle is committed to developing innovative medicines that result
in meaningful improvements in patients’ lives. Eagle’s
commercialized products include PEMFEXY®, RYANODEX®, BENDEKA®,
BELRAPZO®, TREAKISYM® (Japan), and BYFAVO® and BARHEMSYS® through
its wholly owned subsidiary Acacia Pharma Inc. Eagle’s oncology and
CNS/metabolic critical care pipeline includes product candidates
with the potential to address underserved therapeutic areas across
multiple disease states, and the company is focused on developing
medicines with the potential to become part of the personalized
medicine paradigm in cancer care. Additional information is
available on Eagle’s website at www.eagleus.com.
1
https://bynder.acaciapharma.com/m/403e8c343b2922de/original/Byfavo-PI.pdf
Forward-Looking Statements This press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended, and
other securities law. Forward-looking statements are statements
that are not historical facts. Words and phrases such as
“anticipated,” “forward,” “will,” “would,” “could,” “may,”
“remain,” “potential,” “prepare,” “expected,” “believe,” “plan,”
“near future,” “belief,” “guidance,” and similar expressions are
intended to identify forward-looking statements. These statements
include, but are not limited to, statements with respect to: the
Company’s ability to develop innovative medicines that address
unmet medical needs; Byfavo's role as a sedation gent; and Byfavo's
potential development for other indications. All of such statements
are subject to certain risks and uncertainties, many of which are
difficult to predict and generally beyond the Company’s control,
that could cause actual results to differ materially from those
expressed in, or implied or projected by, the forward-looking
information and statements. Such risks and uncertainties include,
but are not limited to: the impacts of the post- COVID-19
environment and geopolitical factors such as the conflict in
Ukraine; delay in or failure to obtain regulatory approval of the
Company's or its partners’ product candidates and successful
compliance with FDA, European Medicines Agency and other
governmental regulations applicable to product approvals; changes
in the regulatory environment; the uncertainties and timing of the
regulatory approval process; whether the Company can successfully
market and commercialize its product candidates; the success of the
Company's relationships with its partners; the outcome of
litigation involving any of its products or that may have an impact
on any of its products; the strength and enforceability of the
Company’s intellectual property rights or the rights of third
parties; competition from other pharmaceutical and biotechnology
companies and the potential for competition from generic entrants
into the market; unexpected safety or efficacy data observed during
clinical trials; clinical trial site activation or enrollment rates
that are lower than expected; the risks inherent in drug
development and in conducting clinical trials; unanticipated
factors in addition to the foregoing that may impact the Company’s
financial and business projections and guidance and may cause the
Company’s actual results and outcomes to materially differ from its
projections and guidance; and those risks and uncertainties
identified in the “Risk Factors” sections of the Company's Annual
Report on Form 10-K for the year ended December 31, 2022, filed
with the Securities and Exchange Commission (the “SEC”) on March
23, 2023, the Company’s Quarterly Report on Form 10-Q for the
quarter ended March 31, 2023, filed with the SEC on May 9, 2023,
the Company’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2023, filed with the SEC on August 8, 2023 and its other
subsequent filings with the SEC. Readers are cautioned not to place
undue reliance on these forward-looking statements. All
forward-looking statements contained in this press release speak
only as of the date on which they were made. Except to the extent
required by law, the Company undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made.
Investor Relations for Eagle Pharmaceuticals,
Inc.: Lisa M. WilsonIn-Site Communications, Inc. T:
212-452-2793 E: lwilson@insitecony.com
Public Relations for Eagle Pharmaceuticals,
Inc.:Faith Pomeroy-WardT: 817-807-8044E:
faith@eagleus.com
Important Safety Information for
BYFAVO® (remimazolam)
Injection
Indications
BYFAVO is a benzodiazepine indicated for the induction and
maintenance of procedural sedation in adults undergoing procedures
lasting 30 minutes or less.
Important Safety Information
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND
RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID
ANALGESICS
Personnel and Equipment for Monitoring and
Resuscitation
- Only personnel trained in
the administration of procedural sedation, and not involved in the
conduct of the diagnostic or therapeutic procedure, should
administer BYFAVO.
- Administering personnel must
be trained in the detection and management of airway obstruction,
hypoventilation, and apnea, including the maintenance of a patent
airway, supportive ventilation, and cardiovascular
resuscitation.
- BYFAVO has been associated
with hypoxia, bradycardia, and hypotension. Continuously monitor
vital signs during sedation and during the recovery
period.
- Resuscitative drugs, and
age- and size-appropriate equipment for bag-valve-mask–assisted
ventilation must be immediately available during administration of
BYFAVO.
Risks From Concomitant Use With Opioid Analgesics and
Other Sedative-Hypnotics
Concomitant use of benzodiazepines, including BYFAVO,
and opioid analgesics may result in profound sedation, respiratory
depression, coma, and death. The sedative effect of intravenous
BYFAVO can be accentuated by concomitantly administered CNS
depressant medications, including other benzodiazepines and
propofol. Continuously monitor patients for respiratory depression
and depth of sedation.
Contraindication
BYFAVO is contraindicated in patients with a history of severe
hypersensitivity reaction to dextran 40 or products containing
dextran 40.
Personnel and Equipment for Monitoring and
Resuscitation
Clinically notable hypoxia, bradycardia, and hypotension were
observed in Phase 3 studies of BYFAVO. Continuously monitor vital
signs during sedation and through the recovery period. Only
personnel trained in the administration of procedural sedation, and
not involved in the conduct of the diagnostic or therapeutic
procedure, should administer BYFAVO. Administering personnel must
be trained in the detection and management of airway obstruction,
hypoventilation, and apnea, including the maintenance of a patent
airway, supportive ventilation, and cardiovascular resuscitation.
Resuscitative drugs, and age- and size-appropriate equipment for
bag-valve-mask–assisted ventilation must be immediately available
during administration of BYFAVO. Consider the potential for
worsened cardiorespiratory depression prior to using BYFAVO
concomitantly with other drugs that have the same potential (e.g.,
opioid analgesics or other sedative-hypnotics). Administer
supplemental oxygen to sedated patients through the recovery
period. A benzodiazepine reversal agent (flumazenil) should be
immediately available during administration of BYFAVO.
Risks From Concomitant Use With Opioid Analgesics and
Other Sedative-Hypnotics
Concomitant use of BYFAVO and opioid analgesics may result in
profound sedation, respiratory depression, coma, and death. The
sedative effect of IV BYFAVO can be accentuated when administered
with other CNS depressant medications (eg, other benzodiazepines
and propofol). Titrate the dose of BYFAVO when administered with
opioid analgesics and sedative-hypnotics to the desired clinical
response. Continuously monitor sedated patients for hypotension,
airway obstruction, hypoventilation, apnea, and oxygen
desaturation. These cardiorespiratory effects may be more likely to
occur in patients with obstructive sleep apnea, the elderly, and
ASA-PS class III or IV patients.
Hypersensitivity Reactions
BYFAVO contains dextran 40, which can cause hypersensitivity
reactions, including rash, urticaria, pruritus, and anaphylaxis.
BYFAVO is contraindicated in patients with a history of severe
hypersensitivity reaction to dextran 40 or products containing
dextran 40.
Neonatal Sedation
Use of benzodiazepines during the later stages of pregnancy can
result in sedation (respiratory depression, lethargy, hypotonia) in
the neonate. Observe newborns for signs of sedation and manage
accordingly.
Pediatric Neurotoxicity
Published animal studies demonstrate that anesthetic and
sedation drugs that block NMDA receptors and/or potentiate GABA
activity increase neuronal apoptosis in the developing brain and
result in long-term cognitive deficits when used for longer than 3
hours. The clinical significance of this is not clear. However, the
window of vulnerability to these changes is believed to correlate
with exposures in the third trimester of gestation through the
first several months of life but may extend out to approximately 3
years of age in humans.
Anesthetic and sedation drugs are a necessary part of the care
of children needing surgery, other procedures, or tests that cannot
be delayed, and no specific medications have been shown to be safer
than any other. Decisions regarding the timing of any elective
procedures requiring anesthesia should take into consideration the
benefits of the procedure weighed against the potential risks.
Adverse Reactions
The most common adverse reactions reported in >10% of
patients (N=630) receiving BYFAVO 5-30 mg (total dose) and
undergoing colonoscopy (two studies) or bronchoscopy (one study)
were: hypotension, hypertension, diastolic hypertension, systolic
hypertension, hypoxia, and diastolic hypotension.
Use in Specific Populations
Pregnancy
There are no data on the specific effects of BYFAVO on
pregnancy. Benzodiazepines cross the placenta and may produce
respiratory depression and sedation in neonates. Monitor neonates
exposed to benzodiazepines during pregnancy and labor for signs of
sedation and respiratory depression.
Lactation
Monitor infants exposed to BYFAVO through breast milk for
sedation, respiratory depression, and feeding problems. A lactating
woman may consider interrupting breastfeeding and pumping and
discarding breast milk during treatment and for 5 hours after
BYFAVO administration.
Pediatric Use
Safety and effectiveness in pediatric patients have not been
established. BYFAVO should not be used in patients less than 18
years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed
between these subjects and younger subjects. However, there is a
potential for greater sensitivity (eg, faster onset, oversedation,
confusion) in some older individuals. Administer supplemental doses
of BYFAVO slowly to achieve the level of sedation required and
monitor all patients closely for cardiorespiratory
complications.
Hepatic Impairment
In patients with severe hepatic impairment, the dose of BYFAVO
should be carefully titrated to effect. Depending on the overall
status of the patient, lower frequency of supplemental doses may be
needed to achieve the level of sedation required for the procedure.
All patients should be monitored for sedation-related
cardiorespiratory complications.
Abuse and Dependence
BYFAVO is a federally controlled substance (CIV) because it
contains remimazolam which has the potential for abuse and physical
dependence.
https://bynder.acaciapharma.com/m/403e8c343b2922de/original/Byfavo-PI.pdf
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