22 Jun FDA Approves BAXDELA™ (Delafloxacin) For Skin Infections

MedicalResearch.com Interview with:

Dr. Cammarata

Dr. Sue Cammarata, MD
Chief Medical Officer
Melinta Therapeutics

MedicalResearch.com:   Would you explain what is meant by MRSA?

Response: MRSA is methicillin-resistant Staphylococcus aureus, a type of staph bacteria that is  resistant to many antibiotics. MRSA is noted by the CDC as one of the top 18 drug-resistant bacteria threats to the United States.  (from CDC https://www.cdc.gov/drugresistance/biggest_threats.html  ) 

MedicalResearch.com:   Why is infection with MRSA so serious?

Response:  MRSA can cause skin infections, lung infection and other issues.

If left untreated, MRSA infections can become severe and cause sepsis – a life-threatening reaction to severe infection in the body – and even death.  MRSA can also cause major issues, such as bloodstream infections, pneumonia and surgical site infections in a healthcare setting, such as a hospital or nursing home. “Resistance to first-line drugs to treat infections caused by Staphlylococcus aureus—a common cause of severe infections in health facilities and the community—is widespread. People with MRSA (methicillin-resistant Staphylococcus aureus) are estimated to be 64% more likely to die than people with a non-resistant form of the infection.”  (quote from WHO website http://www.who.int/mediacentre/factsheets/fs194/en/  )  

MedicalResearch.com:   How does one contract a MRSA infection?  

Response: MRSA can be acquired from contact with an infected wound or personal items (e.g., towels, razors) that have touched infected skin. Risk of infection rises when people are in places that involve, skin-to-skin contact, crowding and communal supplies. Those who are at a particularly high risk include athletes, those in daycare and school, military personnel, and those who recently received inpatient medical care. 

MedicalResearch.com:   Are these infections becoming more common?

Response: MRSA infections were once clustered in the hospital setting.  Now MRSA infections are becoming more common in the community setting.

MedicalResearch.com:   What is the background for delafloxacin?

Response: Baxdela™ (delafloxacin) is a fluoroquinolone antibiotic indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. Baxdela exhibits activity against both gram-positive and gram-negative pathogens, including MRSA (methicillin-resistant Staphylococcus aureus), and is available in both intravenous (IV) and oral formulations. 

MedicalResearch.com:   How is it similar and different from other antibiotics?  

Response: Baxdela is a member of the fluoroquinolone class of antibiotics.  Baxdela has demonstrated efficacy vs S. aureus including resistant strains of the pathogen.   Baxdela is the only quinolone antibiotic that can be used in  MRSA infection.   Unlike other fluoroquinolones, Baxdela is not associated with QT prolongation or photosensitivity.

Unlike many recent antibiotics approved for serious skin infections, Baxdela also can treat Gram-negative bacteria, which can be seen in patients with complicated medical histories, such as those with diabetes, renal disease, vascular disease and obesity.  Baxdela has both IV and oral formulations, which increases the options for physicians who are treating these complicated patients.

Our Phase 3 clinical trials evaluated Baxdela versus vancomycin plus aztreonam in adult patients with ABSSSI.  In the intent-to-treat population (ITT), Baxdela was comparable to vancomycin + AZ in the primary endpoint of early clinical response (48-72 hours), as well as the secondary endpoint of clinical success at Day 14. Baxdela was well tolerated, with a similar rate of adverse events in both study arms.  The most frequently reported AEs were diarrhea and nausea, which were mild and self-limiting.

MedicalResearch.com:   For whom should it be prescribed?  

Response: Baxdela™ (delafloxacin) is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria, including both gram-positive and gram-negative pathogens, including MRSA (methicillin-resistant Staphylococcus aureus).

MedicalResearch.com:   What are the main side effects?  

Response: Baxdela was well tolerated with a 0.9% discontinuation rate in the Phase 3 studies due to adverse drug reactions. In addition, Baxdela has not shown any potential for QT prolongation or phototoxicity in definitive clinical studies. There have been no signals of adverse effects on liver function, kidney function, or glucose regulation compared to the comparator in controlled clinical studies. The most common adverse reactions in patients treated with Baxdela were nausea (8%), diarrhea (8%), headache (3%), transaminase elevations (3%), and vomiting (2%).

MedicalResearch.com:   Is it difficult or expensive to use?

Response: Baxdela does not have significant drug interactions.  Doses of antacids or multivitamins should be given separately from Baxdela oral doses.   The two routes of administration – oral and IV – make it easier to give. The oral option may let patients leave the hospital sooner, but in some cases being admitted could be avoided.

The cost per day for Baxdela will be within the range of most branded antibiotics, which is between $250 and $450 per day.

MedicalResearch.com:   What should readers take away from your report?

Response: The approximately 3 million patients hospitalized each year in the U.S. with ABSSSI often present treatment challenges owing to their underlying medical conditions, making optimal antibiotic selection difficult. Baxdela provides a treatment option for adult patients with ABSSSI based on its coverage spectrum, IV and oral dosing flexibility, efficacy and safety profile. The approval of Baxdela demonstrates FDA’s commitment to making new and effective antibiotics available to address unmet needs for hospitalized ABSSSI patients.

MedicalResearch.com:   Is there anything else you would like to add?

Response: Antibiotic resistance is a growing concern, and physicians need more tools in the fight against this threat to modern medicine. Approval of new therapies like Baxdela, which is effective against MRSA and other serious pathogens, provides physicians another option in addressing the challenges of ABSSSI patients.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation: 

FDA APPROVED BAXDELA™ (DELAFLOXACIN) FOR ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

Last Updated on June 22, 2017 by Marie Benz MD FAAD