FDA approves new drug for schizophrenia, promises few side effects

[Craig Nigrelli]

THE F-D-A HAS APPROVED A NEW KIND OF DRUG TO TREAT SCHIZOPHRENIA – THAT TOUTS HAVING FEWER SIDE EFFECTS THAN CURRENT OPTIONS – AFTER SEEING ENCOURAGING RESULTS FROM TRIALS BY THE DRUG’S MAKER.

THE F-D-A APPROVED BRISTOL MYERS SQUIBB’S NEW TREATMENT COBENFY AFTER GETTING POSITIVE RESULTS FROM TWO OF THE COMPANY’S FIVE-WEEK TRIALS OF THE DRUG.

NOW, THE RESULTS OF TWO *YEAR-LONG* STUDIES HAVE BEEN RELEASED AS WELL.

AND WHILE MOST OF THE PARTICIPANTS WHO SIGNED UP FOR THE TRIALS DROPPED OUT BECAUSE OF SIDE EFFECTS – WHICH DOCTORS SAY IS COMMON FOR SCHIZOPHRENIA DRUG TRIALS – THOSE WHO STAYED IN SHOWED SIGNIFICANT IMPROVEMENT.

ONE STUDY FOCUSED ON SEVERELY ILL PATIENTS… WHILE THE OTHER LOOKED AT PEOPLE WHO WERE CONSIDERED MORE STABLE…

OVER THE COURSE OF A YEAR.

AMONG THE SEVERELY ILL PATIENTS – 78 PERCENT DROPPED OUT OF THE STUDY… LEAVING ONLY 35 PARTICIPANTS.

AND JUST OVER HALF OF THOSE IN THE MORE STABLE GROUP STUDY DIDN’T FINISH THE TRIAL – LEAVING 283 PEOPLE WHO DID TAKE THE DRUG FOR A FULL YEAR.

BUT – 69 PERCENT OF THOSE IN THE SEVERELY ILL GROUP WHO DID FINISH THE TRIAL SHOWED MEANINGFUL IMPROVEMENT IN THEIR SYMPTOMS AFTER A YEAR.

AND JUST UNDER A THIRD OF THOSE IN THE MORE STABLE GROUP DID.

THIS DRUG COULD REPRESENT A BREAKTHROUGH IN TREATING SCHIZOPHRENIA – WHICH HAS BEEN NOTORIOUSLY HARD TO CONSISTENTLY TREAT BECAUSE MANY PEOPLE FEEL THE SIDE EFFECTS OUTWEIGH THE BENEFITS.

THIS NEW DRUG WORKS DIFFERENTLY FROM TRADITIONAL ANTIPSYCHOTICS.

INSTEAD OF BLOCKING DOPAMINE RECEPTORS… COBENFY’S MAIN INGREDIENT TARGETS A DIFFERENT RECEPTOR THAT INDIRECTLY BLOCKS DOPAMINE RELEASE.

AND ONE OF ITS OTHER MAIN INGREDIENTS BLOCKS SOME OF THE COMMON SIDE EFFECTS THAT COME WITH SCHIZOPHRENIA MEDS – LIKE NAUSEA, VOMITING, AND INDIGESTION… AND HAS BEEN ASSOCIATED WITH SLIGHT WEIGHT LOSS INSTEAD OF WEIGHT GAIN.

STILL, IT’S NOT CLEAR WHAT SIDE EFFECTS LED PARTICIPANTS TO DROP OUT OF THE TRIAL.

ONE DOCTOR WHO WAS NOT PART OF THE STUDY TOLD THE ASSOCIATED PRESS WE’LL UNDERSTAND MORE AS MORE DOCTORS START PRESCRIBING THE DRUG.

ANOTHER CONCERN IS COST.

COBENFY GOES FOR ABOUT 22-THOUSAND 500 DOLLARS A YEAR – COMPARED TO 540 FOR A GENERIC ANTIPSYCHOTIC AND SOME DOCTORS ARE CONCERNED INSURANCE COMPANIES WILL REQUIRE SCHIZOPHRENIA PATIENTS TO TRY OTHER DRUGS BEFORE THEY CAN MOVE ON TO IT.

CURRENTLY, THERE IS ONE CHEAPER GENERIC THAT IS WIDELY CONSIDERED ONE OF THE BEST TREATMENTS FOR SCHIZOPHRENIA… BUT IT’S NOT USED AS OFTEN BECAUSE IT REQUIRES BLOOD TESTING TO WATCH FOR THE RISK OF SEVERE NEUTROPENIA – A CONDITION THAT CAUSES YOUR BODY TO HAVE A LOW NUMBER OF WHITE BLOOD CELLS, WHICH ARE ESSENTIAL FOR FIGHTING INFECTIONS.

PATIENTS HAVE REPORTED RELAPSES IN SYMPTOMS WHEN THAT MEDICATION WAS DELAYED OVER TESTING REQUIREMENTS.