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COMPANY NAME
start Ilmu Penyakit Kulit Kelamin
SUMMARY
POINTS
The number of gonorrhea cases is rising in GARDP plan to meet the urgent need for
many settings worldwide, and an increasing new drugs to treat gonorrhea ideal and
acceptable
proportion of cases are multidrug-resistant. 01
.
In Woman : include abnormal vaginal discharge,
In MEN : untreated urethral dysuria, lower abdominal discomfort, and
infection can lead to dyspareunia.
epididymitis, reduced 10%20% of female patients develop PID and risk
fertility, and urethral for infertility.
stricture.
4
MULTIDRUG RESISTENT
Sulfonamides, penicillins, early-generation
01
cephalosporins, tetracyclines, macrolides, and
fluoroquinolones can no longer be relied upon. The
extended-spectrum cephalosporins (ESCs, i.e.,
cefixime and ceftriaxone), which represent the last
remaining option for first-line empirical
monotherapy,
pharyngeal infections
The current pipeline for gonorrhea treatments is severely depleted, with only
3 new chemical entities in various stages of clinical development. Two of
these candidates are also being developed for other indications.
Oral fluoroketolide
activity against gram-positive and fastidious gram-negative
Solithromycin bacteria, including N. gonorrhoeae, M. genitalium, and C.
trachomatis
(CempraInc.) with a 100% efficacy for genital, oral, and rectal sites of
infection in men and women. A Phase III trial is ongoing.
COMPANY NAME
FKUII 2017 ILMU PENYAKIT KULIT KELAMIN
Another bacterial topoisomerase II inhibitor, a novel
triazaacenaphthylene with good in vitro activity against a
Gepotidacin wide range of drug-resistant bacteria, including MRSA
(GlaxoSmithKline) (methicillin-resistant Staphylococcus aureus), ESBL
(extended-spectrum -lactamases) producing
Enterobacteriaceae, and N. gonorrhoeae
A Phase II trial was recently completed, and 96.7% and
94.8% cure rates were achieved with doses of 1500 mg and
3000mg mg,
COMPANY NAME
FKUII 2017 ILMU PENYAKIT KULIT KELAMIN
THE UNMET TREATMENT NEEDS CAN BE
SUMMARIZED AS:
12 COMPANY NAME
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The requirements were split for short- and long-term targeted treatment, with each being further
divided between ideal and acceptable profiles. Based on the needs identified above, and in
line with the consensus TPP, GARDP has developed a comprehensive R&D strategy that is
broken down into 4 complementary components.
Component
: Accelerate the development of a new chemical entity. support the conduct of late dev
1
elopment activities (i.e., Phase III and IV trials). also aims to work with the patent holde
rs to optimize the profile of the molecule along the lines of the TPPs.
Component
: Evaluate the potential of existing antibiotics and their combinations. heir efficacy
2
remains to be confirmed in randomized clinical trials. GARDP will aim to better
understand the opportunities and liabilities of existing drugs and seek to identify
optimal combinations through in vitro studies
Component
3 : Explore copackaging and development of fixed-dose combinations.
Component
4 : Support the development of simplified treatment guidelines and foster conservation.
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COMPANY NAME 15
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