us to you will thank joining I and for and recent Stephanie, on you, morning. Thank the discussing business be our In today, the XXXX everyone second this our during remarks quarter July. through in call and Ernie developments
to welcome talk I quarter, December. the the growth about as leadership want committed us have on and his first all to as role gross interim session joined forward As Ernie by and our will morning. for new our Ernie execute members the Through be we since that always, to were we'll Aquestive afterwards. serving I call team team the to Aquestive. team delivered and number of in of look we CFO additional his management to last continuing important key contributing this on priorities earnings second during the and experience Q&A milestones able after of a on the an I Ernie
management Libervant, to XXXX. of our FDA resubmission accepted of for our the for The filing NDA seizure XX, franchise. continue we for the clusters. on has day CNS of goal assigned foremost, a target the PDUFA Buccal mid-July, building and December First focus In FDA Film a
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date treatment, patient our for that of FDA the longer orally and for the in with NDA December comfort doses. of Libervant we've contribution periods and comfort, XXXX, of drug update criteria position accepted delivered demonstrate duration an reengaged communications be to assigned reduced to goal Libervant in advances FDA filing product and is has and or of patient the a a agency treatment we'll that treatment one more between of burden, meets to Convenience administration, the location, considered care. following ease PDUFA our major Now prior
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next advancing Our program. is our priority epinephrine
may recall, you As AQST-XXX this AQST-XXX. program candidates, two and encompasses
candidate, or relating injections. sublingual first-generation trajectory an FDA designation to was unmet the was faster Moreover, satisfies intramuscular the and ahead subcutaneous Fast development film granted that year population in potentially go development to the by given Track last clinical FDA epinephrine of taking Our making our pathway, patient the those need acknowledged and the patients resistant the AQST-XXX, formulation use cheaper. XXX(b)(X) regulatory to
with FDA, and unique further that epinephrine technological deliver epinephrine reactions data sublingually. solution studies AQST-XXX all in is epinephrine-based trials to our a developed two potential first a candidates two plan have meeting coming the Phase administered medications. the strategy our be X the develop to a AQST-XXX. orally to to as anaphylaxis. measurable months outline -- from consistently can data subjects epinephrine. request plasma patient indication top-line FDA We concentrations we that sublingually demonstrate completed that such, can treatment The AQST-XXX rescue PK PK for plan We we've to with had data plan in population transformative separate beyond to X the AQST-XXX including discuss provides outline As of the the evidence the the the allergic of to deliver from that Phase The the
EpiPen PK study oral for to our first-in-human such epinephrine AQST-XXX, second-generation progressing a as potential is The alternative the candidate, injectable well.
study of data the regulatory half FDA anticipate forward the part for shortly complete in second AQST-XXX with meeting a X to thereafter the on a approval obtain anaphylaxis. We We scheduling two for Part track top-line are to XXXX. path of this for and discuss
scripts performance XX% shipped SYMPAZAN first to our of key SYMPAZAN grew Finally, proprietary perform commercial SYMPAZAN to metrics. continues meet quarter pharmacies Throughout first XX% grow. and continued year-over-year. and quarter-over-quarter to product the XXXX,
revenue product. to ongoing growth our group connect even virtually continued to demonstrates prescriptions prescribers in with and continue Our this and grow this net of ability
leading a done of good establishing feel prior the commercial the two complementary potential has strategy team of to Our a have on prescribers our a SYMPAZAN products common footprint. Libervant. to set always has SYMPAZAN our with to efforts launch available that We with job been way
focused We this XX% Libervant prescribers company company's to to in by a we fall, base with and SYMPAZAN launch XXXX. right Libervant that addition, anticipate saw in we're will diazepam. penetration of our of through are cash prepare as terms be approximately SYMPAZAN the sales In the once continue our into expand, as major the prescriber proprietary with currently into on in net growth scripts. the company's XX% technology epilepsy In for focused products. the of PharmFilm important conclusion, business care the of of also to group a will prescribers nasal patient advancing over and formulations summer to contribution potentially with of successful become patients. XX% and the continued prescribers multiple those they progress provided over focused scripts contributor prescribers, And approved. rescue positive also the They writing we group will SYMPAZAN for position of with familiar
If it's shortly for is Our XXXX launch at December following sales market focus granted approved begin time. team force the the commercial the market Libervant, access PDUFA after launch immediately and that that will expanding date. if to continuing U.S. approved of and access approval on
data X anaphylaxis of the part reporting study this progressing AQST-XXX in study for PK two for Part First-in-human X half we is second of anticipate Phase and top-line XXXX. from
to Thereafter, for with pursue the our with of FDA candidate. meeting parallel, to discuss plan data plan the path completed a two to meeting additional an his in the and request AQST-XXX. AQST-XXX FDA indications to for planning we we're forward from studies discuss And
of initiatives specifics our about look update financial floor throughout we as XXXX. As to all demonstrated revenue, shipments a financial Libervant quarter across relationships as expanding updated launch. grow efficiently our in market as epilepsy outlook, over strategic by turn to that, who'll and the well to all performance and I'd With to advance we provide you the continuing of second like continue preparation We of SYMPAZAN and Ernie, forward results, these potential to outlook.
