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Details:
NRL-1 (diazepam) nasal spray act as inhibitory effects of gamma-aminobutyric acid (GABA), which is investigated for the treatment of epileptic seizures.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: NRL-1
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2023
Details:
Libervant™ (diazepam) buccal film is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity assignment in patients between two and five years of age.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Libervant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2023
Details:
Diazepam Injection is a ready-to-administer prefilled syringes which is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
Lead Product(s): Diazepam
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2023
Details:
Under the expanded agreement, Pharmanovia will cover the Additional Global Markets for Libervant™ (diazepam) buccal film, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Libervant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Atnahs Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 29, 2023
Details:
Libervant is a buccally administered soluble film formulation of diazepam, a benzodiazepine that treats acute uncontrolled seizures in selected patients with refractory epilepsy who are on stable regimens of antiseizure medications.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Libervant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2022
Details:
VALTOCO (diazepam) is a nasal spray for acute treatment of episodes of frequent seizures in adult and pediatric patients 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Valtoco
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2022
Details:
VALTOCO (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Valtoco
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2022
Details:
VALTOCO (diazepam) is a prescription medicine used for the short-term treatment of seizure clusters (also known as “acute repetitive seizures”) in patients 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Valtoco
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2022
Details:
Libervant™ is a buccally, administered film formulation of diazepam, intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from patient’s usual seizure pattern in patients with epilepsy 12 years of age and older.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Libervant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pharmanovia
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement September 28, 2022
Details:
VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from an individual's usual seizure pattern in adult and pediatric patients 6 years of age and older.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Valtoco
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2022
Details:
Mean total Quality-of-Life for VALTOCO® (diazepam nasal spray) scores in patients reporting data at one or more timepoints demonstrated a clinically important improvement during the 12-month study.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Valtoco
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2022
Details:
VALTOCO® (diazepam) is indicated for acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age and older.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Valtoco
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2022
Details:
The VALTOCO® (diazepam nasal spray) CIV, data indicate that patients using the therapy had a statistical and clinically significant increase in the time between their seizure clusters, or SEIzure cluster interVAL (SEIVAL) over a 12-month period.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Valtoco
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2022
Details:
VALTOCO (diazepam nasal spray) is a treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures) that are distinct from an individual’s usual seizure pattern in adult and pediatric patients 6 years of age and older.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Valtoco
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2022
Details:
VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL, is approved for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Valtoco
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
Details:
Fifth patent combined with a growing body of clinical data demonstrate safety and effectiveness of VALTOCO (diazepam nasal spray) in this patient population, enhancing potential to expand clinical and commercial value.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Valtoco
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2022
Details:
Final results from long-term, open-label, repeat-dose Phase 3 study of VALTOCO® (diazepam nasal spray) for episodes of frequent seizure activity include findings on ease of dosing and quality of life.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Valtoco
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2022
Details:
Aculys Pharma signed licensing agreement with Neurelis, for the development and commercialization of VALTOCO (diazepam nasal spray), approved by the FDA in the United States for the acute treatment of seizure clusters in patients with epilepsy six years of age and older.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Valtoco
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Neurelis
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 26, 2022
Details:
Aquestive developed Libervant as an alternative to more invasive, inconvenient, and difficult to administer device driven products, including a rectal gel and nasal spray, for patients with refractory epilepsy. Libervant™ is a buccally, administered soluble film of diazepam.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Libervant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2021
Details:
The agreement provides access to $30 million in capital contingent on FDA approval and U.S. market access for Libervant. The FDA has accepted for filing the resubmission of the New Drug Application (NDA) for Libervant Buccal Film for the management of seizure clusters.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Libervant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 09, 2021
Details:
Aquestive is developing Libervant as an alternative to Diastat (diazepam rectal gel), the current standard of care rescue therapy for patients with refractory epilepsy which, as a rectal gel, is invasive, inconvenient, and difficult to administer.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Libervant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2021
Details:
Funds will enhance growth and commercial penetration of company’s lead orphan drug product, VALTOCO® (diazepam nasal spray), and support pipeline development and expansion.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Valtoco
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cormorant Asset Management
Deal Size: $114.0 million Upfront Cash: Undisclosed
Deal Type: Series D Financing March 09, 2021
Details:
Food and Drug Administration (FDA) has provided further guidance to Aquestive regarding the information to be included in the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the management of seizure clusters.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Libervant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2021
Details:
Resubmitted revised dosing regimen for Libervant to FDA in December 2020, as committed. Multiple clinical trials demonstrate that AQST-108 can consistently deliver epinephrine.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Libervant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 07, 2021
Details:
The proceeds will help to execute on advancing company's key clinical and commercial initiatives, including the resubmission of its NDA for FDA approval of lead product Libervant™ Buccal Film and ongoing clinical trial for AQST-108.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Libervant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: MARATHON PHARMS
Deal Size: $85.0 million Upfront Cash: Undisclosed
Deal Type: Agreement November 23, 2020
Details:
The FDA provided feedback that Xeris’ drug development program for XP-0863 could advance directly into a Phase 3 registration study in both pediatric and adult patients with epilepsy.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: XP-0863
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2020
Details:
Data continue to support the unique clinical attributes for Neurelis' lead product, VALTOCO® (diazepam nasal spray), the first and only nasal spray treatment for seizure cluster rescue in pediatric patients 6 years of age and older, adolescents, and adults.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Valtoco
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2020
Details:
U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for management of seizure clusters.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Libervant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2020
Details:
Upon completion of the clinical study, Neurelis plans to submit a supplemental NDA (sNDA) with the FDA to expand VALTOCO's label to include patients aged 2 and older. Chambliss said the company plans to file the sNDA in 2021.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Valtoco
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 23, 2020
Details:
XP-0863 Phase 1b results and regulatory feedback support direct to Phase 3 registration study in both pediatric and adult patients with epilepsy.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: XP-0863
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 30, 2020
Details:
Ansiolin® (diazepam) is a benzodiazepine indicated to treat anxiety and other somatic or psychiatric conditions associated to anxiety syndrome, while it is also indicated for insomnia.
Lead Product(s): Diazepam
Therapeutic Area: Psychiatry/Psychology Product Name: Ansiolin
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Neuraxpharm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition June 26, 2020
Details:
Xeris’ IM diazepam maintains higher concentration over longer time period versus standard of care.
Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2020
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