A New Oral Treatment Offers Hope Against Rising Gonorrhea Rates

(BPT) - Gonorrhea may be one of the world's oldest known sexually transmitted infections (STIs), but it remains one of today's toughest public health challenges, driven in part by antibiotic resistance, barriers to care, and the lack of new treatments over the past two decades until now.

According to the Centers for Disease Control and Prevention (CDC), more than 540,000 new infections occur in the U.S. each year.[i] The highest rates are seen among sexually active men ages 20-24, though anyone who has unprotected sex can be at risk.[ii]

Antibiotic Resistance is Making Treatment Harder

Caused by the bacterium Neisseria gonorrhoeae, gonorrhea can infect the genitals, rectum, and throat in both men and women. When left untreated, it can lead to serious complications such as pelvic inflammatory disease, infertility, and ectopic pregnancy in women, or painful inflammation and infertility in men. It can also increase the risk of contracting or spreading HIV, and pregnant women can pass the infection to their babies during childbirth.[iii]

Once thought of as easily treated, gonorrhea is now evolving into what experts call "super gonorrhea" - strains that no longer respond to the antibiotics we've relied on for decades, including cephalosporins, our last line of defense. Until now, the only recommended treatment in the U.S. was a single injection of ceftriaxone, effective but not always convenient or preferred by patients.

A New Oral Treatment Option is Offering Hope

At a time when new treatment options are urgently needed, the U.S. Food and Drug Administration (FDA) recently approved NUZOLVENCE^® (zoliflodacin) for oral suspension, a single-dose oral antibiotic for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeaein adults and pediatric patients 12 years and older weighing atleast 35 kg. Clinical studies show this oral treatment is an alternative tothe current commonly used injectable treatment, offering a simple, needle-free option that can be taken discreetly at home.

Avoid use of NUZOLVENCE during pregnancy; obtain a pregnancy test prior to use. The most common adverse reactions are headache, dizziness, nausea, and diarrhea. Laboratory abnormalities (neutropenia, leukopenia) were also observed.

This breakthrough offers new hope; however, prevention remains crucial. Practicing safer sex, using condoms, getting regular STI screenings, and maintaining open communication with partners can help prevent the spread of infections. If you test positive, it is important to seek prompt treatment and inform your partners to protect your own health and the health of your community.

To learn more about the newly approved oral treatment and full prescribing information, visit www.nuzolvence.com.

Important Safety Information (ISI)

Indication and Usage

Indication

NUZOLVENCE^® is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg.

Usage to Reduce Development of Drug-Resistant Bacteria:To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZOLVENCE and other antibacterial drugs, NUZOLVENCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Contraindications

• Known history of hypersensitivity to NUZOLVENCE.
• Concomitant use with moderate or strong CYP3A4 inducers because this is predicted to result in decreased plasma concentrations of zoliflodacin and may reduce the NUZOLVENCE efficacy.

Warnings and Precautions

• Embryo-Fetal Toxicity: Potential Risk for Pregnant Females:
  • Based on data from animal studies, NUZOLVENCE may cause fetal harm when administered to a pregnant female at clinically relevant doses. Avoid use during pregnancy. Advise pregnant females about the potential risk to the fetus with maternal exposure to NUZOLVENCE. Obtain a pregnancy test prior to initiation in persons of reproductive potential.
• Embryo-Fetal Toxicity: Potential Risk Related to Males with Female Partners of Reproductive Potential:
  • Based on data from an animal toxicity study, the risk of early pregnancy loss may be increased in female partners of males treated with NUZOLVENCE. Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after NUZOLVENCE administration.
• Testicular Toxicity and Risks to Male Fertility:
  • Based on findings from animal studies, NUZOLVENCE may cause testicular toxicity and impair male fertility. An assessment of spermatogenesis has not been conducted in humans. Advise males that NUZOLVENCE may cause testicular toxicity and impair male fertility.
• Hypersensitivity Reactions:
  • Hypersensitivity reactions, including rash and pruritus, have been reported in patients receiving NUZOLVENCE.Before therapy with NUZOLVENCE is instituted, carefully inquire about previous hypersensitivity reactions to NUZOLVENCE. If an allergic reaction to NUZOLVENCE occurs, discontinue NUZOLVENCE and institute appropriate supportive measures.
• Clostridioides difficile Infection (CDI):
  • CDI has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
• Development of Drug-Resistant Bacteria:
  • Prescribing NUZOLVENCE in the absence of a proven or strongly suspected bacterial infection or 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 common adverse reactions (≥2%) are headache, dizziness, nausea, and diarrhea. Laboratory abnormalities (neutropenia, leukopenia) were also observed.

Drug Interactions

Concomitant use with moderate or strong CYP3A4 inducers is contraindicated.

Use in Specific Populations

• Pregnancy: Based on findings from animal studies, NUZOLVENCE may cause fetal malformations or increased embryo-fetal loss when administered to a pregnant female.A postmarketing descriptive pregnancy safety study is available for NUZOLVENCE. If exposure occurs during pregnancy, pregnant females or their healthcare providers should report the pregnancy to Entasis Therapeutics at 1-800-651-3861.
• Lactation: There are no data on the presence of zoliflodacin in either human or animal milk, effects on the breastfed infant, or effects on milk production. If NUZOLVENCE is present in breast milk, intestinal flora alteration in the breastfed infant could occur.
• Females and Males of Reproductive Potential: Based on animal studies, NUZOLVENCE may cause fetal malformations when administered to a pregnant female at clinically relevant doses. Additionally, based on data from an animal study, the risk of early pregnancy loss may be increased in partners of males treated with NUZOLVENCE.
  • Pregnancy Testing: Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with NUZOLVENCE.
  • Contraception: Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after their single-dose treatment of NUZOLVENCE.
  • Infertility: Based on data from repeat-dose animal toxicity and fertility studies, NUZOLVENCE may cause testicular toxicity and impair male fertility.
• Pediatric Use: The safety and effectiveness of NUZOLVENCE in pediatric patients younger than 12 years of age or weighing less than 35 kg have not been established.
• Geriatric Use: Clinical studies of NUZOLVENCE did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.

Reporting Adverse Events

You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact:

U.S. Food and Drug Administration

1-800-FDA-1088

www.fda.gov/medwatch

Innoviva Specialty Therapeutics™

1-800-651-3861

medinfo@istx.com

Before administering, please see the Full Prescribing Information forNUZOLVENCE.

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