— New Drug Application for investigational product HP-3070 under FDA
review —
MIAMI & JERSEY CITY, N.J.–(BUSINESS WIRE)–Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu
Pharmaceutical Co., Ltd., announced today that the primary and key
secondary efficacy endpoints and safety results from the pivotal Phase
III study for HP-3070 (asenapine) transdermal drug delivery system
(TDDS), an investigational product for the treatment of schizophrenia,
will be featured as an oral presentation at the 74th Society of
Biological Psychiatry (SOBP) Annual Meeting in Chicago, May 16 – 18,
2019.
The oral presentation will feature data from the pivotal HP-3070 Phase
III clinical study, highlighting HP-3070’s efficacy in the treatment of
schizophrenia, as well as the transdermal patch’s safety and
tolerability profile.
Details for the upcoming presentation are listed below:
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SOBP Presentation: |
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Abstract Title: |
Efficacy and Safety of an Asenapine Transdermal Patch (Asenapine Transdermal System, HP-3070) in the Treatment of Adults with Schizophrenia: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 6-Week Inpatient Study |
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Abstract Number: | 3004934 | |||
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Session Date/Time: |
Oral presentation will occur during the “Novel Tools and Techniques for Disease Prediction, Progression and Intervention” session on May 18, 2019 from 3:00-4:45 PM with the oral presentation scheduled from 4:30-4:45 PM |
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Location: | Marquette Room, Hilton Chicago | |||
“We are excited to share our research at this prestigious meeting with
the psychiatric community who help identify, treat and manage patients
with schizophrenia,” said Dr. David Walling, Ph.D., investigator from
the HP-3070 pivotal Phase III study as well as author and presenter on
the HP-3070 presentation. “Schizophrenia is often difficult to treat,
and having multiple treatment options for patients is crucial as
individuals have unique needs. The data presented here are encouraging
to patients and their families who are living with schizophrenia and who
may benefit from delivery of medication via a patch. If approved,
HP-3070 will not only be a novel treatment option to add to the
armamentarium, but would be the first and only transdermal antipsychotic
for the treatment of schizophrenia.”
This randomized, double-blind, placebo-controlled Phase III clinical
trial evaluated the efficacy and safety of HP-3070 in 617 patients
diagnosed with schizophrenia. The primary endpoint of the study was
change from baseline in the Positive and Negative Syndrome Scale (PANSS)
total score at Week 6 vs placebo. The study results showed that when
compared to placebo, HP-3070 achieved statistically significant
improvement from baseline in PANSS total score.
The systemic safety profile for HP-3070 is consistent with that known
for asenapine. The most common treatment-emergent adverse events
observed in the clinical trial were application site reaction, headache
and extrapyramidal disorder.
The primary and key secondary efficacy endpoints and safety results from
the pivotal Phase III study for HP-3070 will also be featured at the
American Society of Clinical Psychopharmacology (ASCP) 2019 Annual
Meeting in Scottsdale, AZ from May 28 – 31, 2019.
About HP-3070
Asenapine is a second generation atypical antipsychotic currently
available as a sublingual formulation for the treatment of schizophrenia
in adults. HP-3070 is an investigational asenapine-containing
Transdermal Drug Delivery System (TDDS), developed by Hisamitsu
Pharmaceutical, to be applied to the skin for the treatment of
schizophrenia. If approved by the U.S. Food and Drug Administration
(FDA), HP-3070 may provide a novel treatment option for patients,
caregivers, and physicians, as the first and only transdermal patch
antipsychotic available for the treatment of schizophrenia in the U.S. A
New Drug Application (NDA) for HP-3070 is under review by the FDA. The
NDA is supported by a robust clinical program, including nine clinical
studies, which establish the safety and efficacy profile of HP-3070. The
development of HP-3070 represents Noven and Hisamitsu Pharmaceutical’s
commitment to improving the lives of the community of patients who live
with schizophrenia.
About Schizophrenia
Schizophrenia is a severe, chronic psychiatric disease with a
heterogeneous course and symptom profile. The symptoms associated with
schizophrenia are disabling and lifelong, and greatly affect a patient’s
quality of life and social functioning. Symptoms such as hallucinations
and delusions usually start between ages 16 and 30. Schizophrenia
presents clinically as negative (affective flattening, social
withdrawal, and restriction in the fluency and productivity of thought
and speech and in the initiation of goal-directed behavior), positive
(delusions, hallucinations, disorganized speech, and disorganized or
catatonic behaviors) and cognitive symptoms. Cognitive symptoms such as
impairment in sustained attention, impaired executive functioning, and
impaired working memory may also be present.1
About Noven Pharmaceuticals, Inc.
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company
engaged in the research, development, manufacturing, marketing and sale
of prescription pharmaceutical products. Noven’s mission is to develop
and offer pharmaceutical products that meaningfully benefit patients
around the world, with a commitment to advancing patient care through
transdermal drug delivery. Noven is a stand-alone operating subsidiary
of Japan-based Hisamitsu Pharmaceutical Co., Inc., serving as
Hisamitsu’s U.S. platform in prescription pharmaceuticals, and helping
Hisamitsu bring the benefits of patch therapy to the world. For
information about Hisamitsu, visit http://global.hisamitsu/.
1 National Institute of Mental Health. Schizophrenia.
[Internet]. Available from: https://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml
Accessed April 2019.
Contacts
Monica Lara
Noven Pharmaceuticals, Inc.
305-253-1916