Pen­ny stock play­er Adamis gets an­oth­er CRL for high-dose nalox­one as shares crater

The FDA has once again shut the door on mi­cro cap biotech Adamis Phar­ma­ceu­ti­cals’ high dose nalox­one in­jec­tion.

Reg­u­la­tors hand­ed down the pro­gram’s sec­ond CRL in near­ly 12 months, Adamis an­nounced Mon­day, send­ing the pen­ny stock spi­ral­ing. The new re­jec­tion came as a re­sult of new chem­istry, man­u­fac­tur­ing and con­trols is­sues, though Adamis not­ed that none of the prob­lems stemmed from the “ex­tracta­bles and leach­ables test­ing” prob­lems that caused the first thumbs down.

“To me, it is very sur­pris­ing to have new is­sues brought up this late in the re­view process,” CEO Den­nis Car­lo said in a state­ment. “We be­lieve the com­ments and rec­om­men­da­tions stat­ed in the CRL can be ad­dressed and over­come.”

In­vestors shunned shares at the news, send­ing Adamis $ADMP stock plung­ing rough­ly 41% in Mon­day trad­ing.

The San Diego-based biotech works on spe­cial­ty prod­ucts, seek­ing to de­vel­op low­er-cost al­ter­na­tives to drugs al­ready on the mar­ket. Adamis’ high-dose nalox­one in­jec­tion was aimed at treat­ing opi­oid over­dos­es, as prod­ucts like Nar­can and Evzio gen­er­al­ly use less than Adamis’ pro­posed 5 mg/0.5 mL dose.

Adamis re-sub­mit­ted its ap­pli­ca­tion in May, about six months af­ter first be­ing turned away. Car­lo said at the time that he felt the ad­di­tion­al da­ta ad­dressed all the is­sues re­lat­ed to the FDA’s let­ter, and the com­pa­ny had en­tered in­to a dis­tri­b­u­tion agree­ment for the pro­gram that would have, pend­ing ap­proval, to­taled up to $26 mil­lion in up­front cash and mile­stone pay­ments.

But reg­u­la­tors ev­i­dent­ly saw some­thing they didn’t like — again. Both CRLs for this can­di­date have now dealt with CMC con­cerns, and Adamis has re­quest­ed a Type A meet­ing to re­solve any out­stand­ing ques­tions.

This is not the first Adamis pro­gram to face re­jec­tion at the FDA. Back in Feb­ru­ary 2019, the agency hand­ed back the com­pa­ny’s ap­pli­ca­tion for a low­er-cost erec­tile dys­func­tion drug, say­ing Adamis did not pro­vide enough da­ta for a re­view. The ex­per­i­men­tal drug was a fast-dis­in­te­grat­ing ver­sion of tadalafil, the same ac­tive in­gre­di­ent in Eli Lil­ly’s Cialis.

Adamis’ main prod­uct is an ep­i­neph­rine in­jectable called Sym­jepi, which is used to treat al­ler­gic re­ac­tions and ana­phy­lac­tic shock sim­i­lar to My­lan’s block­buster Epipen. The plan was to use the same de­liv­ery sys­tem for their nalox­one in­jec­tion as Sym­jepi. The biotech is al­so de­vel­op­ing cheap­er al­ter­na­tives in a range of acute res­pi­ra­to­ry dis­eases, such as Covid-19, in­fluen­za, asth­ma and COPD.

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