Johnson & Johnson (JNJ) recently announced that the US Food and Drug Administration (FDA) issued a complete response letter (CRL) for the company’s moderate-to-severe chronic pain treatment Nucynta (tapentadol).
The drug is already in the market as an immediate release formulation for the treatment of moderate-to-severe chronic pain in patients 18 years and older. The CRL applies for the New Drug Application (NDA) for tapentadol to be marketed as an extended release (ER) formulation.
The regulatory body has not asked Johnson & Johnson to conduct additional trials for evaluating the safety and efficacy of the ER formulation of the drug. However, the FDA has requested for data demonstrating the conversion of the current ER formulation to a different ER formulation that is designed to be more resistant to breaking or crushing.
Johnson & Johnson in-licensed the marketing rights of tapentadol from Grünenthal Group for the United States, Canada and Japan. Earlier in June, Johnson & Johnson extended its agreement with Grünenthal to include the registration, manufacturing and marketing of tapentadol for both the immediate- and prolonged-release formulations in Asia Pacific, Latin America, Africa and certain European countries.
We currently have a Neutral recommendation on Johnson & Johnson, which is supported by a Zacks #3 Rank (short-term Hold rating). We view the CRL for the ER formulation of tapentadol as a minor setback for the company, given the fact that the FDA has asked only for more information and not for an additional study to prove the safety and efficacy of the drug.
Though concerned about Johnson & Johnson’s over-the-counter product recall and pricing pressures seen in the EU, we believe the company is taking measures to counter falling sales of key products through in-licensing deals and acquisitions that would bring new products to market. The diversity and strength of the company’s businesses should ensure strong growth ahead.
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
Zacks Investment Research
