our will session of Thank the this And second joining In joined be I you, Stephanie. an members we thank to for the morning. will call during today, afterward. everyone update and team quarter. us as our Aquestive by on provide John the And on additional you leadership the remarks Q&A business for always,
the people colleagues, Our do interact the and who our always patients we safety products. caregivers as key our company with, with a the business start priorities of and with
the of taking to this advance company's a company's involved people continues be proprietary medicines chronic product to including continue, needed and our carefully Suboxone. FP&A access business and manufacturing including have that, of patients, important managed use products manufacturing. and in continuing we the sure ensure healthy, processes to for business our to period, progressing leaders keep We've company's to facility colleagues ability, R&D the safe continuing our all we our elements continued licensee of the During key to such The safe, company. market extraordinary managers that the our responsibility business, Sympazan, review while various best steps initiatives, are that for as supporting key of the the product, are we as all and Sympazan, work to produce
Our time and has to therefore, to face this majority continued possible the sales to be virtually, continued access face. period. And to of where patients prescribers, team the prescribed these during Sympazan has
We key continue as progress it our to company. significant of relates make for focus the to areas
the First, progress are of we as to view product measurement candidate, Sympazan important. in Aquestive in market Sympazan is the continued our the prescriber continuing second same make to Libervant. that to base prescribers quarter potential all areas
sublingual of in Investigational PharmFilm development late application of using formulation, the for This the is kind proprietary for delivering June, oral film systemic New Drug epinephrine in treatment Next, anaphylaxis. its first we AQST-XXX. Aquestive's candidate a filed therapeutic technology
to Our rescue medication for the this expect initiate in first FDA orally-administered year. third the We by AQST-XXX, IND will first accepted if quarter trials clinical has be population. approved, epinephrine-based of we PK believe this the and the been patient
Next, the of approval Aquestive work seeking continues to FDA with Libervant. in
on or licensee continues responding working agency clinical manufacturing inspections to have of information perform as in product, providing there the questions the In during Aquestive's requests view, and information their We and to to date. no expected. surprises with their inspections our our sites. have Suboxone, been been lead
addition, EU eroding In launching and the for anticipate in partially the that We in Suboxone launch of United months. in States. Suboxone the volume the will Indivior that offset the received we be that in Suboxone understand it coming approval just EU region will
Finally, in with that the a launched sublingual Aquestive potential product a the for apomorphine has Sunovion's approval anticipated associated FDA KYNMOBI, monetization a received May. royalties of process
to the sales approval to launched, In entitled payment, worldwide be KYNMOBI. net milestones addition on triggering we once will of royalties
the of for in discuss focus each key these let's company. more of areas Now, detail
focused our First, building CNS on franchise. remain we
of the of prescribers prescribers Sympazan, advancing with commercialization Libervant. potential substantially are whose overlap We
the of by our FDA approved capabilities the technology is build access. in product the out to PharmFilm of complementary continues the prove commercial a support aim processes for commercial Sympazan our Libervant profile to and opportunity. Our Libervant raise precursor preparation as of and of market US in the launch if for
opportunity Sympazan for for positioning to important if measures of view groups provide for those a grow technology. helping is with suffering commercialization visits of our to advocacy practitioners, as patients, to stage. result a stronger from groups in of expected block, drive the COVID-XX a All important this access. conversations caregivers at proposition meaningful as as all patients the to face healthcare providing face well for with building PharmFilm payers, LGS, by Libervant to of value the key the we launch, as on others caregivers, an Sympazan profitability Sympazan about market approved crisis, in XXXX, efforts continued Despite restrictions direct prescribers relating of value and The Sympazan an our acceptance
have prescription shipment and market Shipment volumes QX further sequentially over The quarter multiple focus Sympazan also those growth base now since scripts. and of to period launch. the We continue XX% highest XXX% X% same XX% focused penetration. prescribers grow. have quarter-over-quarter penetration represented its in to for volume year. XX% continues We since prescribing the last over grown on by prescribers. our group writing with of end the QX, a of of
continues The was rate on sales was Virtually, us and ramp the Sympazan position care has continue with health The state XX%. of payer XX% prescribers We Medicaid And a and Medicaid, target and eliminated help and at it commercial of patients face adopted challenges Libervant. coverage also our to digital providers to COVID-XX pandemic payers claims up team. with some QX covered with healthcare our to access to mid-March a acceptance regions. rapidly XX%. on since commercial has face all launch paid for for remotely tools live The XX% our their will have currently actual point team staff basis. over in lives created for of believe access providers time. clinics of field-based for We Sympazan have frequent their engage
also with to phases While face at healthcare expect states have this to we'll opportunities face as to time, different have of interactions we well. some providers, but them to for are continue virtual in reopening with continue visits
team's Libervant. to our to the revenue and and Sympazan regulations, grow team product been for when difficult to demonstrates last During patient of is with have we The continued year. ability, what needs to virtually with that we prescribers prescriptions Sympazan was net our is launch and the continue maintain that that connect penetration build successful our launched this even sales foundation time. strategically we've the best growth intended product a hard compliant with connections We work the pandemic, through an that to sales worked will believe important ensured prescriber a safe accomplishing also able for do Sympazan. local to we but the continue developed be market have, the and and community of
key the well in positioned a for position access successfully sales would this commercial access, in restricted if As US company for potential bag, environment. if teams quickly to We said approval, relationships, $XXX we peak. million we a prescribers, that its payer marketing we and Libervant with put our revenue have product base with Libervant, granted complementary are combined would and net stream marketing approved before, Aquestive represent a even a sales launch at of infrastructure, believe in anticipate US
Now, let's turn AQST-XXX. to
in we this late filed the with year. expected, the for of As AQST-XXX June FDA IND
development at Based date, under that with trials. be will trials. agency On FDA by to from the of planned on and proceed of clinical safety meeting July XXX(b)(X) pathway. reviewed of comprised interactions confirmation least received IND the FDA with the by confirmed be will regulatory our program IND that clinical expect this review XX FDA As program approval February, it the two pre PK this the we that the the the we in completed could its at our year, we concluded
trials administered crossover the to the an PK the pharmacodynamics designed first clinical sublingual pharmacokinetics current will before of that epinephrine as trial injection. of and be the This of first epinephrine quarter. expect as administered a film commence that the of We to compare end study will
do our development possibly on PK information XXXX. from of FDA additional the XXXX program the a We we once efforts, As pivotal would confirm updates forward, which all as second with additional the path plan trial, first meet and include our half over we have develops. trial information we to in our will with of provide
goal filing XXXX. Next, communicated, a Libervant the NDA XX, was as September and of accepted assigned for of we date previously January this PDUFA year in
approval indication our for FDA is there scheduled. not not any of the ongoing from have to are COVID-XX with pandemic at on interaction Libervant XX, of that have impact track the regarding as point, and that, believe this an a in September reason no decision we We XXXX seen terms the
date, goal simultaneously. Given may the orphan not period we for approval FDA, both that the will a be feedback will made short cannot be approved and the receive is the decision orphan the of decisions exclusivity by within we some be following received different PDUFA on if possibility groups time day. exclusivity There sure decisions that that until
We we our months perspective, received completely From respond The well to date. of the engaged and responding and the to their clinical with agency requests, information or have information requests received able requests our there the have providing the surprises all timely are over ongoing information have past manufacturing requests in few date. inspections inspections information expectations information, manner been their been sites. as line no in with in in our as to to to a been and
patient We driven the also available a US diazepam-based to delivered Libervant currently contribution for orally the by operations. FDA represent the for to first product device patient marketing Libervant patient will, We within if can to the we to delivered demonstrate would and of seizure the believe the based care FDA attributes Libervant guidance the why has compared as required seeking an as expand treatment meaning regulations to available major a or are to of approved, that orally FDA more to major FDA as clusters. product demonstrate manage considered contribution choice care. access be one
question foundational will of and on for the about the Libervant continue date. not spending approval, of we least our PDUFA we is will Subject FDA a that what to choices, position decision that assure launching position do and dialogue cannot on orphan market, we do the we the to FDA's goal at clarity the expenses pre-launch on access the the and the to the and cannot and with an this we the FDA spend be, on until risk we and participate assure to marketing be any Recognizing for to drug clarity and we approval are Libervant Sympazan capabilities While continues thoughtful appropriately FDA's element approval that. Libervant. scheduled have to of committed Libervant prudent our having are the prior have managing commercial will
we here ago, the KYNMOBI are any moments process, mentioned in that, middle launched comment further potential a I In this will of as Finally, of not the have specifics. monetization our few we understandably process we for on royalties.
quarter any an such We of the at the and, third as floor John We provide will release I'd transaction an results forward update colleague, course, provide update complete time financial over you the these XXXX. we at John? the With third at quarter financial of time updating outlook. make initiatives of our who'll our time look advance that, we our and turn earnings. performance Maxwell, specifics like to we'll my provide throughout to of to of as
