Eagle Pharmaceuticals, Inc. (“Eagle” or the “Company”) (Nasdaq:
EGRX) today announced that the Company will release its 2022 second
quarter financial results on Tuesday, August 9, 2022, before the
market opens.
Scott Tarriff, President and Chief Executive
Officer, and Brian Cahill, Chief Financial Officer, will host a
conference call to discuss the results as follows:
Date |
Tuesday,
August 9, 2022 |
Time |
8:30 a.m. ET |
Toll free (U.S.) |
800-445-7795 |
International |
203-518-9843 |
|
|
Webcast (live and replay) |
www.eagleus.com, under the “Investor Relations” section |
|
|
A replay of the conference call will be available
for two weeks after the call's completion by dialing 800-938-0997
(U.S.) or 402-220-1541 (International) and entering conference call
ID EGRXQ222. The webcast will be archived for 30 days at the
aforementioned URL.
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 vasopressin, 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. Additional information is
available on Eagle’s website at www.eagleus.com.
Contact:Investor Relations
for Eagle Pharmaceuticals, Inc:Lisa M. WilsonT:
212-452-2793E: lwilson@insitecony.com
Important Safety Information for BYFAVO™
(remimazolam)
Injection1
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.
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