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Kesin Pharma Announces FDA Approval and U.S. Availability of
LIKMEZ
™ (
metronidazole
) Oral Suspension
2023-11-14
·
BioSpace
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LIKMEZ
™ (
metronidazole
) Oral Suspension, the First and Only FDA-Approved Liquid Option for Patients with Adherence Hurdles such as
Dysphagia
, Difficulty Swallowing Kesin Pharma Launches Novel Formulation of Mainstay Anti-Infective, Metronidazole Kesin Pharma: Solutions for Better Health™ OLDSMAR, Fla.--(BUSINESS WIRE)-- Kesin Pharma Corporation, a pharmaceutical company focused on innovative Specialty brands and Unit Dose formulations, announced today that the U.S. Food and Drug Administration (FDA) has approved
LIKMEZ
™ (
metronidazole
) oral suspension, 500 mg/5 mL. Available now,
LIKMEZ
™ is the first and only FDA-approved ready-to-use oral liquid
metronidazole
in the U.S. market.
LIKMEZ
™ is a novel presentation of a mainstay antibiotic drug, reinvented to address common adherence issues. Kesin is the exclusive U.S. commercialization partner for
LIKMEZ
™ through its collaboration with Saptalis Pharmaceuticals, LLC, the developer and NDA holder of the product.
LIKMEZ
™ is a novel proprietary liquid formulation of
metronidazole
for patients who may struggle with
dysphagia
, difficulty swallowing, or high taste sensitivities. These potential compliance and persistency obstacles can lead to treatment discontinuation and inefficient treatment outcomes, including
rebound infection
.
LIKMEZ
™ is approved for the treatment of
trichomoniasis
and
anaerobic bacterial infections
in adults and
amebiasis
in adults and pediatric patients.
LIKMEZ
™ comes in a 200 mL bottle as a strawberry peppermint flavored suspension, with a 24-month shelf life and does not require refrigeration.
Metronidazole
has been shown to be carcinogenic in mice and rats, and the most common adverse reactions to
metronidazole
include
nausea
,
headache
,
anorexia
,
vomiting
,
diarrhea
,
abdominal cramping
,
epigastric distress
, and
constipation
.
LIKMEZ
™ addresses inherent risks associated with crushing tablets for those patients needing a liquid formulation and eliminates the potential inconsistences associated with extemporaneously compounding
metronidazole
prescriptions. Additionally, compounding can amplify the pronounced bitter, metallic taste of
metronidazole
tablets, which can also negatively influence patients’ adherence to therapy. “
LIKMEZ
™ is for patients and providers who need a liquid option for those faced with adherence obstacles due to taste sensitivities or difficulty swallowing. An increasing number of patients can benefit from a safe and efficacious product that can support medication adherence. We are very excited with our first brand launch which is part of our upcoming pipeline of novel products, designed to address unmet patient needs and bring value to the healthcare system,” said Narasimhan Mani, President & CEO of Kesin Pharma Corporation. “We are pleased with our partnership with Saptalis Pharmaceuticals, the NDA holder and manufacturer of
LIKMEZ
™. The timely approval of this NDA505(b)(2) presents a significant opportunity for Kesin Pharma to bring a value-added product to the market,” said Narasimhan Mani.
LIKMEZ
™ will be available through most full-line wholesalers and retail pharmacies. To learn more and view Full Prescribing Information, including complete BOXED WARNING and additional Safety Information see . About Kesin Pharma Kesin Pharma Corporation, based in Oldsmar, FL, is a specialty pharmaceutical company with deep experience and strong capabilities in commercial sales & marketing, distribution, and market access. Kesin’s mission is to provide unique healthcare solutions to patients through our portfolio of strategic, value-driven brand and unit-dose products. Kesin Pharma works closely with patients, payers, and provider partners to bring to market innovative pharmaceutical products to better address unfulfilled needs and enhance patient adherence and accessibility. For more information, visit . About Saptalis Pharmaceuticals, LLC Saptalis Pharmaceuticals, LLC is a rapidly growing pharmaceutical company specialized in development, manufacturing, and commercialization of generic and innovative products in liquid and semi-solid dosage forms. Located in the Hauppauge Industrial Park on Long Island, NY, USA, Saptalis has fully equipped Research & Development Laboratories and state of the art commercial scale manufacturing facility designed to meet FDA cGMP requirements. For more information, visit . Important Safety Information INDICATIONS AND USAGE
LIKMEZ
™ (
metronidazole
) is a nitroimidazole antimicrobial indicated for:
Trichomoniasis
in adults
Amebiasis
in adults and pediatric patients Anaerobic
Bacterial Infections
in adults To reduce the development of drug-resistant bacteria and maintain the effectiveness of
LIKMEZ
™ and other antibacterial drugs,
LIKMEZ
™ should be used only to treat or prevent
infections
that are proven or strongly suspected to be caused by bacteria. WARNING: POTENTIAL FOR CARCINOGENICITY
Metronidazole
has been shown to be carcinogenic in mice and rats. Avoid unnecessary use of
LIKMEZ
™. Reserve
LIKMEZ
™ for use in the following indications:
trichomoniasis
,
amebiasis
, and
anaerobic bacterial infections
. See full prescribing information for complete BOXED WARNING. CONTRAINDICATIONS Hypersensitivity Reactions:
LIKMEZ
is contraindicated in patients with known
hypersensitivity
to
metronidazole
or other nitroimidazole derivatives. Psychotic Reactions with
Disulfiram
:
LIKMEZ
is contraindicated in patients who have used
disulfiram
within the last two weeks. Use of oral
metronidazole
is associated with psychotic reactions in alcoholic patients who were using
disulfiram
concurrently. Interaction with
Alcohol
:
LIKMEZ
is contraindicated in patients who consume
alcohol
or products containing
propylene glycol
during and for at least three days after
LIKMEZ
therapy. Use of oral
metronidazole
is associated with a disulfiram-like reaction to alcohol, including
abdominal cramps
,
nausea
,
vomiting
,
headaches
, and
flushing
.
Cockayne Syndrome
:
LIKMEZ
is contraindicated in patients with
Cockayne syndrome
. WARNINGS AND PRECAUTIONS Potential for Carcinogenicity:
Metronidazole
has been shown to be carcinogenic in mice and rats. Reserve
LIKMEZ
for use in the following indications:
trichomoniasis
,
amebiasis
, and
anaerobic bacterial infections
. Central and Peripheral Nervous System Effects:
Encephalopathy
,
aseptic meningitis
,
peripheral neuropathy
(including
optic neuropathy
) and
convulsive seizures
have been reported with
metronidazole
. The appearance of abnormal neurological signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy. Fungal Superinfections: Known or previously unrecognized
candidiasis
may present more prominent symptoms during therapy with
LIKMEZ
and requires treatment with an antifungal agent.
Blood Dyscrasias
:
LIKMEZ
is a nitroimidazole and should be used with care in patients with evidence of or history of
blood dyscrasia
. Total and differential leukocyte counts are recommended before and after therapy. Drug-Resistant Bacteria: Prescribing
LIKMEZ
in the absence of a proven or strongly suspected
bacterial infection
or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions The most serious adverse reactions in patients treated with
metronidazole
have been
convulsive seizures
,
encephalopathy
,
aseptic meningitis
,
optic and peripheral neuropathy
, the latter characterized mainly by numbness or
paresthesia
of an extremity. Persistent
peripheral neuropathy
has been reported in some patients receiving prolonged administration of
metronidazole
. In addition,
headache
,
syncope
,
dizziness
,
vertigo
,
incoordination
,
ataxia
,
confusion
,
dysarthria
,
irritability
,
depression
,
weakness
weakness
weakness
weakness
weakness
weakness
weakness
, and
insomnia
have been reported. The most common adverse reactions reported: Gastrointestinal: The most common adverse reactions reported have been referable to the gastrointestinal tract, particularly
nausea
, sometimes accompanied by
headache
,
anorexia
, and occasionally
vomiting
;
diarrhea
;
epigastric distress
; and
abdominal cramping
and
constipation
. Mouth: A sharp, unpleasant metallic taste is not unusual. Furry tongue,
glossitis
, and
stomatitis
have occurred; these may be associated with a sudden overgrowth of Candida which may occur during therapy. Dermatologic:
Erythematous rash
and
pruritus
. Hematopoietic: Reversible
neutropenia
(
leukopenia
); reversible
thrombocytopenia
. Cardiovascular: QT prolongation has been reported, particularly when
metronidazole
was administered with drugs with the potential for prolonging the QT interval. Flattening of the T‑wave may be seen in electrocardiographic tracings. Hypersensitivity:
Urticaria
,
erythematous rash
,
Stevens-Johnson Syndrome
,
toxic epidermal necrolysis
,
flushing
,
nasal congestion
,
dryness
of the mouth (or vagina or vulva), and
fever
. Renal:
Dysuria
,
cystitis
,
polyuria
,
incontinence
, and a sense of pelvic pressure. Instances of darkened urine have been reported by approximately one patient in 100,000. Although the pigment which is probably responsible for this phenomenon has not been positively identified, it is almost certainly a metabolite of
metronidazole
and seems to have no clinical significance. Other: Proliferation of Candida in the vagina,
dyspareunia
, decrease of libido,
proctitis
, and fleeting
joint pains
sometimes resembling “
serum sickness
”. Cases of
pancreatitis
, which generally abated on withdrawal of the drug, have been reported. Patients with Crohn’s disease are known to have an increased incidence of
gastrointestinal and certain extraintestinal cancers
. There have been some reports in the medical literature of breast and colon cancer in Crohn’s disease patients who have been treated with
metronidazole
at high doses for extended periods of time. A cause-and-effect relationship has not been established. Crohn’s disease is not an approved indication for
LIKMEZ
. DRUG INTERACTIONS Disulfiram: Psychotic reactions have been reported in alcoholic patients who are using
metronidazole
and
disulfiram
concurrently.
LIKMEZ
is contraindicated in patients who have taken
disulfiram
within the last two weeks. Alcoholic Beverages:
LIKMEZ
is contraindicated in patients who consume alcohol or products containing
propylene glycol
during and for at least 3 days after therapy with
LIKMEZ
. Use of
LIKMEZ
with
alcohol
or other products containing
propylene glycol
is associated with a disulfiram-like reaction (
abdominal cramps
,
nausea
,
vomiting
,
headaches
, and
flushing
)
Warfarin
and other Oral Anticoagulants:
Metronidazole
has been reported to potentiate the anticoagulant effect of
warfarin
and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. When
LIKMEZ
is prescribed for patients on this type of anticoagulant therapy, prothrombin time and INR should be carefully monitored.
Lithium
: In patients stabilized on relatively high doses of
lithium
, short-term use of
LIKMEZ
has been associated with elevation of serum lithium concentrations and signs of lithium toxicity due to the interaction between
metronidazole
and
lithium
. Monitor serum lithium and serum creatinine concentrations for several days after beginning treatment with
LIKMEZ
to detect any increase that may precede clinical symptoms of
lithium toxicity
.
Busulfan
:
Metronidazole
has been reported to increase plasma concentrations of
busulfan
, which can result in an increased risk for serious
busulfan
toxicity. Do not administer
LIKMEZ
concomitantly with
busulfan
unless the benefit outweighs the risk. Inhibitors of CYP450 Liver Enzymes: The simultaneous administration of
LIKMEZ
and drugs that decrease microsomal liver enzymes, such as
cimetidine
, may prolong the half-life and decrease plasma clearance of
metronidazole
. Inducers of CYP450 Liver Enzymes: The simultaneous administration of
LIKMEZ
and drugs that induce microsomal liver enzymes, such as
phenytoin
or
phenobarbital
, may accelerate the elimination of
metronidazole
, resulting in reduced plasma concentrations of
metronidazole
. Impaired clearance of
phenytoin
has also been reported. Drugs that Prolong the QT Interval: QT prolongation has been reported. Drug/Laboratory Test Interactions:
Metronidazole
may interfere with certain types of determinations of serum chemistry values. Values of zero may be observed. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary: Most studies did not show an increased risk for
congenital anomalies
or other adverse fetal outcomes following
metronidazole
exposure during pregnancy. Lactation Risk Summary: There are no data on the effects of
metronidazole
on milk production. Pediatric Use: The safety and effectiveness of
LIKMEZ
for the treatment of
amebiasis
have been established in pediatric patients. The safety and effectiveness of
LIKMEZ
for the treatment of
trichomoniasis
and
anaerobic bacterial infections
have not been established in pediatric patients. Geriatric Use: In elderly geriatric patients, monitoring for
LIKMEZ
associated adverse events is recommended. Decreased liver function in geriatric patients can result in increased concentrations of
metronidazole
that may necessitate adjustment of
metronidazole
dosage. Renal Impairment: Patients with
end-stage renal disease
may excrete
metronidazole
and metabolites slowly in the urine, resulting in significant accumulation of
metronidazole
metabolites. Monitoring for
LIKMEZ
associated adverse events is recommended. Hepatic Impairment: Patients with hepatic impairment metabolize
metronidazole
slowly, with resultant accumulation of
metronidazole
in the plasma. For patients with severe hepatic impairment, reduce the dose of
LIKMEZ
by 50%. For patients with mild to moderate hepatic impairment, no dosage adjustment is needed but these patients should be monitored for
LIKMEZ
associated adverse reactions. OVERDOSAGE There is no specific antidote for
metronidazole
overdose; therefore, management of the patient should consist of symptomatic and supportive therapy. In case of an overdose, patients should contact a physician, poison control center, or emergency room. Please see full Prescribing Information, including BOXED WARNING at
LIKMEZ
™ and the stylized
LIKMEZ
™ logo are registered trademarks of Saptalis Pharmaceuticals, LLC.
LIKMEZ
™ is marketed by Kesin Pharma Corporation. © 2023 Kesin Pharma Corporation. All rights reserved.
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