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US 11,596,673 B2Granted
Long lasting effect of new botulinum toxin formulations
AssigneeMedy-Tox, Inc.
InventorsHyun Ho Jung, Gi Hyeok Yang, Hyun Jee Kim, Chang Hoon Rhee
Life of this patent
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Abstract
The invention relates to the use of an animal-protein-free botulinum toxin composition to treat a disease, disorder or condition in a patient in need thereof whereby the animal-protein-free botulinum toxin composition exhibits a longer lasting effect in the patient compared to an animal-protein-containing botulinum toxin composition.
Claims13
A method of treating glabellar lines in a patient, the method, comprising:
- locally administering to the patient a composition comprising:
- 150 kDa serotype A botulinum toxin,
- polysorbate,
- an amino acid, and
- at least one additional stabilizer selected from the group consisting of a sugar, a sugar alcohol, and an ionic compound,
- wherein the composition does not comprise an animal-derived product or recombinant human albumin;
- and wherein the amount of 150 kDa serotype A botulinum toxin in the composition is approximately equivalent to the amount of 150 kDa serotype A botulinum toxin in about 20 units of the animal-protein containing composition comprising botulinum toxin type A 900 kDa 50 units, human serum albumin 0.25 mg, and sodium chloride 0.45 mg;
- wherein the composition has a greater length of effect compared to about 20 units of the animal-protein containing composition comprising botulinum toxin type A 900 kDa 50 units, human serum albumin 0.25 mg, and sodium chloride 0.45 mg, when administered in the same manner for the treatment of glabellar lines as that of the botulinum toxin composition;
- wherein,
- the composition is administered to the patient in approximately equal amounts at five injection sites;
- the five injections consist of one injection site in the procerus muscle, and two injection sites in each corrugator supercilii muscle;
- and
- the method significantly alleviates moderate to severe glabellar lines as shown by a responder rate of about 50% or greater as measured by physician live assessment at maximum frown from at least 16 weeks after administration of the composition to the patient.
10 more elements
A method of treating glabellar lines in a patient, the method, comprising:
- locally administering to the patient a composition comprising
- (i) 150 kDa serotype A botulinum toxin;
- (ii) polysorbate,
- (iii) methionine, and
- (iv) sucrose;
- wherein the composition does not comprise an animal-derived product or recombinant human albumin;
- and wherein the amount of 150 kDa serotype A botulinum toxin in the composition is approximately equivalent to the amount of 150 kDa serotype A botulinum toxin in about 20 units of the animal-protein containing composition comprising botulinum toxin type A 900 kDa 50 units, human serum albumin 0.25 mg, and sodium chloride 0.45 mg;
- wherein the composition has a greater length of effect compared to about 20 units of the animal-protein containing composition comprising botulinum toxin type A 900 kDa 50 units, human serum albumin 0.25 mg, and sodium chloride 0.45 mg, when administered in the same manner for the treatment of glabellar lines as that of the botulinum toxin composition;
- wherein,
- the composition is administered to the patient in approximately equal amounts at five injection sites consisting of one injection site in the procerus muscle, and two injection sites in each corrugator supercilii muscle;
- and
- the method significantly alleviates moderate to severe glabellar lines as shown by a responder rate of about 50% or greater as measured by physician live assessment at maximum frown from at least 16 weeks after administration of the composition to the patient.
9 more elements
A method of treating glabellar lines in a patient, the method, comprising:
- locally administering to the patient a composition comprising
- (i) 150 kDa serotype A botulinum toxin;
- (ii) polysorbate,
- (iii) methionine, and
- (iv) sodium chloride;
- wherein the composition does not comprise an animal-derived product or recombinant human albumin;
- and wherein the amount of 150 kDa serotype A botulinum toxin in the composition is approximately equivalent to the amount of 150 kDa serotype A botulinum toxin in about 20 units of the animal-protein containing composition comprising botulinum toxin type A 900 kDa 50 units, human serum albumin 0.25 mg, and sodium chloride 0.45 mg;
- wherein the composition has a greater length of effect compared to about 20 units of the animal-protein containing composition comprising botulinum toxin type A 900 kDa 50 units, human serum albumin 0.25 mg, and sodium chloride 0.45 mg, when administered in the same manner for the treatment of glabellar lines as that of the botulinum toxin composition;
- wherein,
- the composition is administered to the patient in approximately equal amounts at five injection sites consisting of one injection site in the procerus muscle, and two injection sites in each corrugator supercilii muscle;
- and
- the method significantly alleviates moderate to severe glabellar lines as shown by a responder rate of about 50% or greater as measured by physician live assessment at maximum frown from at least 16 weeks after administration of the composition to the patient.
9 more elements
Dependencies are inferred from the claim text.